File Layout for Releasable 510(k)s
(Format Updated 2/20/2014)
510(K) NUMBER
APPLICANT
CONTACT
STREET 1
STREET 2
CITY
STATE
DOMESTIC ZIP
DEVICE NAME
DATE RECEIVED
DECISION DATE
DECISION
ADVISORY COMMITTEE
PRODUCT CODE
Contains either "SUMMARY" or "STATEMENT"
SUMMARY indicates that a summary of safety and effectiveness information is available from FDA
STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant
Advisory Committee Code under which the product was classified, based on the product code
Blank
Denotes the type of 510(k) submission:
Traditional
Special
Abbreviated
Evaluation of Automatic Class III Designation
THIRD PARTY FLAG - Y or N - Indicates if the 510(k) was reviewed by a Third Party
EXPEDITED REVIEW FLAG - Y, N or null - Indicates if the 510(k) was granted expedited review status.
COUNTRY CODE
FOREIGN POSTAL CODE
510(k) DECISION CODES Substantially Equivalent Codes
KD Substantially Equivalent - Kit with Drugs
PR Substantially Equivalent - Proposed Recision
PT Substantially Equivalent - Subject to Tracking & PMS
RN Substantially Equivalent - Rescind Non-Substantial Equivalence
SA Substantially Equivalent - Awaiting Device Approval
SD Substantially Equivalent with Drug
SE Substantially Equivalent
SF Substantially Equivalent - Awaiting Future Policies
SI Substantially Equivalent - Market after Inspection
SK Substantially Equivalent - Kit
SN Substantially Equivalent for Some Indications
SP Substantially Equivalent - PostMarket Surveillance Required
ST Substantially Equivalent - Subject to Tracking Reg.
SU Substantially Equivalent - With Limitations
SW Substantially Equivalent - Awaiting Drug Approval
Non-Substantially Equivalent Codes
FB Subject to 515(b) - Requires PMA
NE Not Substantially Equivalent
SC Not Substantially Equivalent - Cannot Market
SL Not Substantially Equivalent - Improper Label
RE Rescind Substantial Equivalence
UD Unable to Determine Equivalence
UO Unable to Determine Equivalence - Outstanding Drug Issue
UR Not Substantially Equivalent - Unreliable Data
OD Unable to Determine Equivalence - Outstanding Device Issue
Other Decision Codes
CR Additional Information Requested; Applicant can not respond within 30 days
DB Forwarded to Drugs/Biologics
DD Deleted/Duplicate
DE Deleted
DR Drug (CDER) Review Required
EX Exempted by Regulation
GP General Purpose Article
K4 Closeout Letter Issued
NA Not Actively Regulated
ND Not a Device
NF Not a Finished Product
NR Not a Required Submission
PE Preamendment Exempt
RC Reconditioner/Remanufacturer
TR Transitional Device
WD Withdrawn by Applicant