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Vital Pep

by Vital Signs, Inc. 510(k)

Active United States

510(k) K984468

Overview

The device is a spirometer, therapeutic (incentive), as defined in the nomenclature authority. It is identified by the model name Vital Pep and product code BWF.

It was cleared through the FDA 510(k) process under number K984468 with a substantially equivalent decision. The device is classified as class II and is associated with the anesthesiology medical specialty. It is manufactured by Vital Signs, Inc. and was received for review on December 16, 1998, with a decision date of June 1, 1999.

AI-generated from registry data, 25 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 NumberK984468 Date1 Jun 1999ClearedStatusActive

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
BWF
Device Class
Class II
Regulation
21 CFR Part 868.5690
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Vital Pep device used for?

    The Vital Pep is an incentive spirometer designed to encourage deep breathing and lung expansion, typically used in postoperative or respiratory therapy settings to prevent atelectasis and improve pulmonary function.

  • How is the Vital Pep supplied and is it reusable?

    The Vital Pep is supplied as a single-use, non-sterile therapeutic incentive spirometer intended for one patient only; it is not designed for cleaning, disinfection, or reuse due to infection control risks and material degradation.

  • What model and product code identify the Vital Pep device?

    The Vital Pep is identified by its model name 'Vital Pep' and product code BWF, which distinguishes it from other spirometers in the Vital Signs, Inc. product line and is referenced in its FDA 510(k) submission K984468.