Skip to content

Peep Valve

by International Respiratory Systems, Inc.

510(k) K923618

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK923618 Date3 Aug 1992ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2434-2020 FDA Class II initiated 15 Jan 2019
    • Terminated Z-2436-2020 FDA Class II initiated 15 Jan 2019
    • Terminated Z-2435-2020 FDA Class II initiated 15 Jan 2019

    A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits.

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  • Withdrawn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

Overview

AI-generated summary, 6 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 Peep Valve is a breathing attachment designed to provide positive end-expiratory pressure. It functions as a component used in respiratory care to maintain pressure within the airway.

This device is authorized under FDA 510(k) clearance K923618. It is categorized under the anesthesiology medical specialty.

Other devices from International Respiratory Systems, Inc.