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  4. Device Approvals and Clearances
  5. 510(k) Clearances
  6. File Layout for Releasable 510(k)s
  1. 510(k) Clearances

File Layout for Releasable 510(k)s

(Format Updated 3/08/2023)

510(K) NUMBER

APPLICANT

CONTACT

STREET 1

STREET 2

CITY

STATE

COUNTRY CODE

DOMESTIC ZIP

POSTAL_CODE

DATE RECEIVED

DECISION DATE

DECISION

REVIEW 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

CLASSIFICATION ADVISORY COMMITTEE - the code under which the product was classified, based on the product code

Blank

TYPE OF 510(k) SUBMISSION: Traditional, Special or Abbreviated

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.

DEVICE NAME

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

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