Skip to content

Barrierflex-Pf Pulmonary Function Testing Filter

by Bird Life Design 510(k)

Active United States

510(k) K934540

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934540 Date19 Oct 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
CAH
Device Class
Class II
Regulation
21 CFR Part 868.5260
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Barrierflex-Pf Pulmonary Function Testing Filter is a bacterial, breathing-circuit filter used for pulmonary function testing. It is classified as a Filter, Bacterial, Breathing-circuit, with a device class of 2, and is used in the medical specialty of Anesthesiology.

The Barrierflex-Pf Pulmonary Function Testing Filter is supplied with an FDA 510(k) clearance, K934540, and is regulated under 868.5260. It is a traditional clearance type, substantially equivalent device, with a product code of CAH. The filter is designed for use in pulmonary function testing, and is intended to fit various spirometers and PFT devices.

Other devices from Bird Life Design

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Barrierflex-Pf Pulmonary Function Testing Filter used for?

    The Barrierflex-Pf Pulmonary Function Testing Filter is used for pulmonary function testing, and is intended to fit various spirometers and PFT devices.

  • Is the Barrierflex-Pf Pulmonary Function Testing Filter supplied sterile?

    The description does not specify if the Barrierflex-Pf Pulmonary Function Testing Filter is supplied sterile, but it is designed as a bacterial filter for breathing circuits.

  • What regulatory clearance does the Barrierflex-Pf Pulmonary Function Testing Filter have?

    The Barrierflex-Pf Pulmonary Function Testing Filter has FDA 510(k) clearance, with a clearance number of K934540, and is regulated under 868.5260.