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Information on Releasable 510(k)s

• General Information
• Federal Register Notices
• Search the Releasable 510(k) Database
• Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered
• Downloadable 510(k) Files

General Information

510(k) Overview
Class I 510(k) Exemptions, FDA Talk Paper - February 6, 1996
The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
Screening Checklist for all Premarket Notification 510(k) Submissions
Reclassification Letters
FDA Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices

Federal Register Notices

Medical Devices; Exemptions From Premarket Notification and Reserved Devices; Class I (2/2/98)
Medical Devices; Exemptions from Premarket Notification; Class II Devices (1/21/98)

Search the Releasable 510(k) database

You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format :

Device Classification Name:
Regulation Number:
510(k) Number:
Device Name:
Applicant:
Contact:
Product Code:
Date Received:
Decision Date:
Decision:
Classification Advisory Committee:
Review Advisory Committee:
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

Summary/Statement/Purged Indicator:

• "Purged" indicates a 510k application released to the public under the Freedom of Information Act with trade secret/confidential commercial or privacy information exempted.

Types:

• Traditional
• Special
• Abbreviated
• Rescission
• Evaluation of Automatic Class III Designation

Reviewed by Third Party (Y/N)
Expedited Review (Y/N)

Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered.

Listings are normally available about the 5th of each month for the prior month. Summaries are in pdf format and are available about 3 weeks after the monthly listing is posted. The 510(k) number is the indication of the link if the summary is available.

2008 Listings

2007 Listings

2006 Listings

2005 Listings

2004 Listings

2003 Listings

2002 Listings

2001 Listings

2000 Listings

1999 Listings

Listings of CDRH Substantially Equivalent (SE) 510(k) Final Decisions for months prior to 1999 can be found using 510(k) Final Decisions. The results of the search will be in a format similar to the current monthly listings.

Downloadable 510(k) Files

You can download any of the following zipped files, each of which contains information about the releasable 510(k)s for the time frame indicated. Information about how to unzip these files is available. Each record in the file is 272 characters in length. These files are replaced monthly usually on the 5th of each month. In addition there is a file description and an explanation of some of the codes used in the file. You can also download or search the Product Code Classification Database.

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Updated September 5, 2008

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