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Buffalo Filter Replacement Filter #BSPF030

by Buffalo Filter Co., Inc. 510(k)

Active United States

510(k) K943226

Overview

This device is an apparatus, exhaust, surgical, as defined in the device data. It is a replacement filter designed for use in surgical exhaust systems.

It is supplied as a single-use component and is authorized under FDA 510(k) clearance K943226. The device is intended for use in general and plastic surgery settings, with no claims regarding sterility, MRI safety, or reusability made in the provided data.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943226 Date10 Jul 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
FYD
Device Class
Class II
Regulation
21 CFR Part 878.5070
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the BUFFALO FILTER REPLACEMENT FILTER #BSPF030 used for?

    The BUFFALO FILTER REPLACEMENT FILTER #BSPF030 is a replacement filter designed for use in surgical exhaust systems, intended for general and plastic surgery settings to filter exhaust during procedures.

  • Is the BUFFALO FILTER REPLACEMENT FILTER #BSPF030 supplied as sterile or single-use?

    The device is supplied as a single-use component, meaning it is intended for one-time use and disposal after each procedure; no claims regarding sterility are made in the provided data.

  • What regulatory authorization does the BUFFALO FILTER REPLACEMENT FILTER #BSPF030 have?

    The device is authorized under FDA 510(k) clearance K943226, with a decision date of July 10, 1995, and is classified as substantially equivalent to a predicate device under product code FYD.