P.E.E.P. Valve

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

510(k) Number

K882219 ↗

FDA Product Code

BYE

Device Class

Class II

Regulation

21 CFR Part 868.5965

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Lspi Automatic Ventilator, Model AV3000-100

  Class II

  FDA 510(k) K941871 Active Cleared 9 Jan 1995

• Spiros

  Class II

  FDA 510(k) K915564 Active Cleared 30 Jan 1992

• Lspi Pressure Regulator

  Class I

  FDA 510(k) K936187 Active Cleared 27 Jan 1994

• Lsp Minilator

  Class I

  FDA 510(k) K860516 Active Cleared 21 Feb 1986

• Infant Disposable Bag Mask Resuscitator

  Class II

  FDA 510(k) K922819 Active Cleared 24 Nov 1993

• Autovac

  Class II

  FDA 510(k) K921107 Active Cleared 17 Sep 1992

See all devices from Life Support Products, Inc. →

• What is the P.E.E.P. Valve used for?

  The P.E.E.P. Valve is designed for use in respiratory support systems to maintain positive end-expiratory pressure, which helps keep alveoli open at the end of exhalation and improves oxygenation in patients requiring ventilatory support.

• Is the P.E.E.P. Valve sterile or non-sterile, and is it intended for single-use or reuse?

  The P.E.E.P. Valve is supplied non-sterile and is intended for single-use only, meaning it should not be reprocessed or reused after initial patient contact to ensure safety and performance integrity.

• What regulatory pathway and clearance information applies to the P.E.E.P. Valve?

  The P.E.E.P. Valve is regulated under FDA 510(k) clearance K882219, with product code BYE and regulation number 868.5965, and is classified as a Class II medical device for anesthesiology applications based on substantial equivalence to a predicate device.