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U.S. Department of Health and Human Services

Medical Devices

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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
KDSubstantially Equivalent - Kit with Drugs
PRSubstantially Equivalent - Proposed Recision
PTSubstantially Equivalent - Subject to Tracking & PMS
RNSubstantially Equivalent - Rescind Non-Substantial Equivalence
SASubstantially Equivalent - Awaiting Device Approval
SDSubstantially Equivalent with Drug
SESubstantially Equivalent
SFSubstantially Equivalent - Awaiting Future Policies
SISubstantially Equivalent - Market after Inspection
SKSubstantially Equivalent - Kit
SNSubstantially Equivalent for Some Indications
SPSubstantially Equivalent - PostMarket Surveillance Required
STSubstantially Equivalent - Subject to Tracking Reg.
SUSubstantially Equivalent - With Limitations
SWSubstantially Equivalent - Awaiting Drug Approval
Non-Substantially Equivalent Codes
FBSubject to 515(b) - Requires PMA
NENot Substantially Equivalent
SCNot Substantially Equivalent - Cannot Market
SLNot Substantially Equivalent - Improper Label
RERescind Substantial Equivalence
UDUnable to Determine Equivalence
UOUnable to Determine Equivalence - Outstanding Drug Issue
URNot Substantially Equivalent - Unreliable Data
ODUnable to Determine Equivalence - Outstanding Device Issue
Other Decision Codes
CRAdditional Information Requested; Applicant can not respond within 30 days
DBForwarded to Drugs/Biologics
DDDeleted/Duplicate
DEDeleted
DRDrug (CDER) Review Required
EXExempted by Regulation
GPGeneral Purpose Article
K4Closeout Letter Issued
NANot Actively Regulated
NDNot a Device
NFNot a Finished Product
NRNot a Required Submission
PEPreamendment Exempt
RCReconditioner/Remanufacturer
TRTransitional Device
WDWithdrawn by Applicant