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One-Lung CPAP Device

by Vital Signs, Inc. 510(k)

Active United States

510(k) K901728

Overview

The One-Lung CPAP Device is an attachment for breathing that provides positive end expiratory pressure (PEEP). It is classified as a Class II medical device under regulation number 868.5965 and is intended for use in anesthesiology.

The device received FDA 510(k) clearance (K901728) on August 14, 1990, and was found substantially equivalent to a predicate device. It is manufactured by Vital Signs, Inc. and is supplied as a non-sterile, reusable device for use in clinical settings requiring one-lung ventilation support.

AI-generated from registry data, 19 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 NumberK901728 Date14 Aug 1990ClearedStatusActive

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
BYE
Device Class
Class II
Regulation
21 CFR Part 868.5965
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the One-Lung CPAP Device intended for?

    The One-Lung CPAP Device is intended for use in anesthesiology to provide positive end expiratory pressure (PEEP) as an attachment for breathing during one-lung ventilation support in clinical settings.

  • Is the One-Lung CPAP Device sterile or non-sterile when supplied?

    The device is supplied as a non-sterile, reusable device, meaning it is not provided in a sterile condition and must be cleaned and sterilized by the user before each use in accordance with institutional protocols.

  • Can the One-Lung CPAP Device be reused, and what does that imply for its handling?

    Yes, the device is designed for reuse, which means it must be cleaned, disinfected, or sterilized between uses according to the manufacturer’s instructions and healthcare facility guidelines to ensure patient safety.

  • What regulatory pathway was used for the One-Lung CPAP Device, and what does that indicate about its clearance status?

    The device received FDA 510(k) clearance under the traditional pathway (K901728) on August 14, 1990, and was found substantially equivalent to a predicate device, which means it met the requirements for market clearance without needing a premarket approval application.

  • What classification and regulation number apply to the One-Lung CPAP Device?

    The One-Lung CPAP Device is classified as a Class II medical device under regulation number 868.5965, which governs attachments for breathing that provide positive end expiratory pressure (PEEP) in the anesthesiology specialty.