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ABI Vest Airway Clearance System

by American Biosystems, Inc.

510(k) K993629

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993629 Date21 Jan 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BYI
Device Class
Class II
Regulation
21 CFR Part 868.5665
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The ABI Vest Airway Clearance System is a powered-electric percussor device designed to promote airway clearance or improve bronchial drainage by enhancing mobilization of bronchial secretions through external manipulation of the thorax. It is intended for use when this method is the physician's choice of treatment, in accordance with clinical practice guidelines from the American Association for Respiratory Care (AARC) published in 1991.

The device is supplied as a reusable system and has received FDA 510(k) clearance under K993629, classified as a Class II medical device under regulation number 868.5665. It is manufactured by American Biosystems, Inc. and is indicated for use in clinical settings where external thoracic manipulation is selected as a therapeutic approach for airway clearance.

Other devices from American Biosystems, Inc.

Questions

AI-generated answers, 25 Sep 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 ABI Vest Airway Clearance System used for?

    The ABI Vest Airway Clearance System is designed to promote airway clearance or improve bronchial drainage by enhancing mobilization of bronchial secretions through external manipulation of the thorax, and is intended for use when this method is the physician's choice of treatment in accordance with clinical practice guidelines from the American Association for Respiratory Care (AARC) published in 1991.

  • Is the ABI Vest Airway Clearance System reusable or single-use?

    The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance between patient uses, as indicated in the device description and regulatory documentation.

  • What regulatory pathway was used for the ABI Vest Airway Clearance System?

    The ABI Vest Airway Clearance System received FDA 510(k) clearance under K993629, classified as a Class II medical device under regulation number 868.5665, and was determined to be substantially equivalent to a predicate device through a traditional 510(k) submission.