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PTFE Syringe Filter

by B. Braun Medical Inc. 510(k)

Active United States

510(k) K952918

Overview

The PTFE Syringe Filter is a medical device designed for filtration applications. It is constructed with PTFE (polytetrafluoroethylene) material, which provides chemical resistance and compatibility with various solutions. The filter is intended for use in laboratory and clinical settings to remove particulates and contaminants from fluids.

This device is supplied as a single-use item and is not intended for reuse. It is designed for use in syringe filtration applications and is available in various sizes to accommodate different filtration needs. The PTFE Syringe Filter is FDA 510(k) cleared with product code FMF and is manufactured by B. Braun Medical Inc.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952918 Date15 Sep 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FMF
FDA applicant
B.Braun Medical, Inc.
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the PTFE Syringe Filter used for?

    The PTFE Syringe Filter is designed for filtration applications in laboratory and clinical settings to remove particulates and contaminants from fluids. Its PTFE material provides chemical resistance and compatibility with various solutions.

  • Is the PTFE Syringe Filter reusable or single-use?

    The PTFE Syringe Filter is supplied as a single-use item and is not intended for reuse. This design ensures optimal filtration performance and prevents cross-contamination between samples.

  • What sizes are available for the PTFE Syringe Filter?

    The PTFE Syringe Filter is available in various sizes to accommodate different filtration needs. The specific size options should be confirmed with the manufacturer based on your particular application requirements.

  • What is the regulatory status of the PTFE Syringe Filter?

    The PTFE Syringe Filter is FDA 510(k) cleared with product code FMF. This clearance indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.