FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices
Section VI. of FDA’s Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling outlines six criterion that should be addressed in reprocessing instructions. Criterion 4 recommends that reprocessing instructions should include devices and accessories that are legally marketed. On this page is a table of FDA-cleared liquid chemical sterilants and high level disinfectants, last updated September 2015.
Manufacturer | Active Ingredient(s) | Sterilant Contact Conditions | High Level Disinfectant Contact Conditions |
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K091210 Acecide-C High Level Disnfectant and Sterilant | |||
Best Sanitizers, Inc. | 3100-3400 ppm peracetic acid |
Indication for device sterilization |
7 min at 20ºC 5 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K091890 Extended Use Aldahol High Level Disinfectant | |||
Healthpoint, Ltd. | 3.4% glutaraldehyde 20.1% isopropanol |
Indication for device sterilization |
For processing in a legally marketed Automated Endoscope Reprocessor capable of maintaining solution temperature at 25ºC: 5 min at 25ºC 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K091022 Resert XL HLD High Level Disinfectant | |||
Steris Corporation | 2.0% hydrogen peroxide |
No indication for device sterilization. |
8 min at 20ºC 21 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K090036 and K173256 Steris S40 Sterilant Concentrate |
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Steris Corporation | ≥1820 mg/L peracetic acid |
Indication for device sterilization |
No indication for high level disinfection |
K113015 Aldahol V High Level Disinfectant | |||
Microchem Laboratories, Inc. | 3.4% glutaraldehyde 20.1% isopropanol |
Indication for device sterilization. |
10 min at 20ºC 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K120306 Rapicide OPA-28 High Level Disinfectant | |||
Minntech Corporation | 0.575% ortho-phthalaldehyde |
No indication for device sterilization. |
For Manual Processing: 10 min at 20ºC 28 days Maximum Reuse For processing in a legally marketed Automated Endoscope Reprocessor capable of maintaining solution temperature at 25ºC: 5 min at 25ºC 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K140703 OPA 30 Solution | |||
Ciden Technologies, LLC | 0.6% ortho-phthalaldehyde | No indication for device sterilization. Passes the Modified AOAC Sporicidal Activity Test in 32 hrs at 20°C and 25°C. |
For Manual Processing: |
K041984 Acecide High Level Disnfectant and Sterilant | |||
Best Sanitizers, Inc. | 3300-3800 ppm peracetic acid | No indication for device sterilization. 5 hrs at 25°C 5 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test and by simulated use testing with endoscopes. |
5 min at 25ºC 5 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K051305 TD-5 High-level Disinfectant | |||
CS Medical, L.L.C. | 2.65% glutaraldehyde |
No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 10 hrs at 22 °C. |
5 min at 37.8ºC Single use to be used exclusively with the TD-100 Transesophageal Probe Disinfector. Contact conditions established by simulated use testing with endoscopes. |
K041360 Aldahol III High Level Disinfectant | |||
Healthpoint LTD | 3.4% glutaraldehyde 26% isopropanol |
Indication for device sterilization. 10 hrs at 20° C |
10 min at 20ºC 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K012889 Banicide Advanced for Sterilization and High Level Disinfection | |||
Pascal Company, Inc. | 3.5% glutaraldehyde |
Indication for device sterilization. 10 hrs at 25°C |
45 min at 25°C 30 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K032959 Cidex® OPA Concentrate | |||
Advanced Sterilization Products | 5.75% ortho-phthaldehyde (OPA) |
No indication for device sterilization. In-Use solution (0.05% OPA) passes the AOAC Sporicidal Activity Test in 32 hrs at 50°C. |
5 min at 50ºC Single use – diluted by system For use in the EvoTech Integrated Endoscope Disinfection System only. Contact conditions established by simulated use testing with endoscopes. |
K030004 Cidex OPA Solution | |||
Advanced Sterilization Products | 0.55% ortho-phthaldehyde | No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20°C and 25°C. |
Manual Processing Automated Endoscope Reprocessor (AER) |
K013280 Sterilox Liquid High Level Disinfectant System | |||
Sterilox, Technologies, Inc. | Hypochlorite and Hypochlorous acid 650-675 ppm Active free chlorine |
No indication for device sterilization. Passes the Modified AOAC Sporicidal Activity Test in 24 hrs at 25°C. | 10 min at 25°C Single use - generated on site Contact conditions established by simulated use testing with endoscopes. |
K003087 Sporicidin Sterilizing and Disinfecting Solution | |||
Sporicidin International | 1.12% glutaraldehyde 1.93% phenol/phenate |
Indication for device sterilization. 12 hrs at 25°C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
20 min at 25°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K993042 Rapicide High Level Disinfectant and Sterilant | |||
MediVators, Inc. | 2.5% glutaraldehyde | Indication for device sterilization. 7 hrs 40 min at 35°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes and additional supporting information. |
Automated Endoscope Reprocessor 5.0 min at 35°C 28 days Maximum Reuse (For processing in an AER only with FDA-cleared capability to maintain the solution temperature at 35°C.) Contact conditions established by simulated use testing with endoscopes. |
K991487 °Cidex®OPA Solution High Level Disinfectant | |||
Advanced Sterilization Products | 0.55% ortho-phthaldehyde | No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20°C. | 12 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K974188 °Cetylcide-G Concentrate and Diluent Concentrate | |||
Cetylite Industries, Inc. | 3.2% glutaraldehyde | Indication for device sterilization. 10 hrs at 20°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
40 min at 20°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K974062 MedSci 3% Glutaraldehyde | |||
MedSci, Inc. | 3% glutaraldehyde | Indication for device sterilization. 10 hrs at 25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
25 min at 25°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K972708 EndoSpor Plus Sterilizing and Disinfecting Solution Note: Due to the lack of test strips for monitoring the concentrations of the active ingredients, the reuse period is limited to 14 days. |
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Cottrell Limited | 7.35% hydrogen peroxide 0.23% peracetic acid |
Indication for device sterilization. 180 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
15 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K970230 SporoxTM Sterilizing & Disinfection Solution | |||
Reckitt & Colman Inc. | 7.5% hydrogen peroxide | Indication for device sterilization. 6 hrs at 20°C 21 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
30 min at 20°C 21 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K960513 PeractTM 20 Liquid Sterilant/Disinfectant | |||
Minntech Corporation | 1.0% hydrogen peroxide 0.08% peracetic acid |
Indication for device sterilization. 8 hrs at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
25 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K932922 Procide 14 N.S. | |||
Cottrell Limited | 2.4% glutaraldehyde | Indication for device sterilization. 10 hrs at 20°C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
45 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K932922 OmnicideTM Long Life Activated Dialdehyde Solution | |||
Cottrell Limited | 2.4% glutaraldehyde | Indication for device sterilization. 10 hrs at 20°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
45 min at 20°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K932922 OmnicideTM Plus | |||
Cottrell Limited | 3.4% glutaraldehyde | Indication for device sterilization. 10 hrs at 20°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
45 min at 20°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K931592 Metricide Plus 30 Long-Life Activated Dialdehyde Solution | |||
Metrex Research, Inc. | 3.4% glutaraldehyde | Indication for device sterilization. 10 hrs at 25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide Plus as identical to Cidex Plus. |
90 min at 25°C 28 days Maximum Reuse FDA accepted Metricide Plus as identical to Cidex Plus. |
K931052 Metricide 28 Long-Life Activated Dialdehyde Solution | |||
Metrex Research, Inc. | 2.5% glutaraldehyde | Indication for device sterilization. 10 hrs at 25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide 28 as identical to Cidex Formula 7. |
90 min at 25°C 28 days Maximum Reuse FDA accepted Metricide 28 as identical to Cidex Formula 7. |
K930284 Metricide Activated Dialdehyde Solution | |||
Metrex Research, Inc. | 2.6% glutaraldehyde | Indication for device sterilization. 10 hrs at 25°C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide as identical to Cidex. |
45 min at 25°C 14 days Maximum Reuse FDA accepted Metricide as identical to Cidex. |
K924434 Cidex™ Activated Dialdehyde Solution | |||
Johnson & Johnson Medical Products | 2.4% glutaraldehyde | Indication for device sterilization. 10 hrs at 25°C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
45 min at 25°C 14 days Maximum Reuse Contact conditions based on literature references. |
K924334 Cidex Formula 7™ Long-Life Activated Dialdehyde Solution | |||
Johnson & Johnson Medical Products | 2.5% glutaraldehyde | Indication for device sterilization. 10 hrs at 20-25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
90 min at 25°C 28 days Maximum Reuse Contact conditions based on literature references. |
K923744 Cidex PlusTM 28 Day Solution | |||
Johnson & Johnson Medical Products | 3.4% glutaraldehyde | Indication for device sterilization. 10 hrs at 20-25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
20 min at 25°C 28 days Maximum Reuse Contact conditions based on literature references. |
K914749 Wavicide - 01 | |||
Wave Energy Systems | 2.5% glutaraldehyde | Indication for device sterilization. 10 hrs at 22°C 30 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. |
45 min at 22°C 30 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K080420 Resert XL HLD High Level Disnfectant | |||
Steris Corporation | 2.0% Hydrogen peroxide | No indication for device sterilization. In-Use solution passes the AOAC Sporicidal Activity Test in 6 hrs at 20 °C |
8 min at 20ºC 21 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K070627 Opaciden Solution | |||
Ciden Technologies, LLC |
0.60% ortho-phthalaldehyde (OPA)
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No indication for device sterilization. In-Use solution passes the AOAC Sporicidal Activity Test in 32 hrs at 21 ° C and 32 hrs at 25-27°C. |
For Manual Processing: 12 min at 20ºC 14 days Maximum Reuse For processing in a legally marketed Automated Endoscope Reprocessor capable of maintaining solution temperature at 25ºC: 5 min at 25ºC 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K063159 Sterilox High Level Disinfectant System | |||
Sterilox, Technologies, Inc. | Hypochlorous acid/hypochlorite 400-450 ppm Active free chlorine |
No indication for device sterilization. Passes the Modified AOAC Sporicidal Activity Test in 32 hrs at 30 ° C. |
10 min at 30ºC Single use - generated on site Contact conditions established by simulated use testing with endoscopes. |
K060618 Cidex Activated Dialdehyde Solution | |||
Advanced Sterilization Products | 2.4% glutaraldehyde | 10 hrs at 25 °C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test and by simulated use testing with endoscopes. |
45 min at 25 °C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |