Valve, PEEP

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

510(k) Number

K760230 ↗

FDA Product Code

BYE

Device Class

Class II

Regulation

21 CFR Part 868.5965

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Ohio Absorber

  Class I

  FDA 510(k) K821144 Active Cleared 28 May 1982

• Ohio Disposable Tracheal Tube

  Class II

  FDA 510(k) K810763 Active Cleared 27 Mar 1981

• Ohio Cpu-1 Intensive Care Ventilator

  Class II

  FDA 510(k) K822888 Active Cleared 16 Nov 1982

• Ohio 7000 Electronic Anesthesia Ventil.

  Class II

  FDA 510(k) K821376 Active Cleared 29 Jun 1982

• Ohio Free Flow Vacuum Regulator

  Class II

  FDA 510(k) K801169 Active Cleared 28 Jul 1980

• Non-Reusable Universal Nebulizer Filter

  Class II

  FDA 510(k) K823257 Active Cleared 9 Dec 1982

See all devices from Airco/Ohio Medical Products →

• What clinical settings is the Valve, PEEP intended for, and how does it function in those environments?

  The Valve, PEEP is designed specifically for use in anesthesia and critical care settings, where patients require respiratory support. It functions as a one-way breathing attachment to deliver positive end-expiratory pressure (PEEP) during mechanical ventilation or spontaneous breathing. By maintaining a constant pressure in the lungs at the end of exhalation, it helps improve oxygenation and ventilation, which is critical for patients with compromised lung function, such as those in ICU or undergoing surgical procedures requiring anesthesia.

• Is the Valve, PEEP intended for single-use or can it be reused after sterilization?

  The Valve, PEEP is supplied as a single-use attachment, but it is non-sterile and must be sterilized prior to use. While it is technically reusable after proper sterilization, the manufacturer does not explicitly endorse reuse beyond the initial single-use scenario. Clinicians should follow standard medical device preparation protocols for sterilization if reusing, ensuring compliance with infection control guidelines.

• What regulatory pathway was followed for FDA clearance of the Valve, PEEP, and how does this affect its use?

  The Valve, PEEP received FDA 510(k) clearance (K760230) under the Traditional 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device. This clearance confirms it meets FDA standards for safety and effectiveness as a Class II medical device under the Anesthesiology specialty. Clinicians can rely on this clearance to ensure the device adheres to regulatory requirements for use in anesthesia and critical care settings.

• Are there different sizes or models of the Valve, PEEP, and how would I identify the correct one for my patient?

  The Valve, PEEP is listed under OpenFDA with multiple registration numbers (e.g., 3013557562, 3006061749, etc.), which may correspond to variations in size or configuration. However, the provided data does not specify distinct sizes or models beyond its core function as a PEEP attachment. To ensure compatibility, verify the product code (BYE) and consult manufacturer documentation or your facility’s inventory system to confirm the correct fit for your respiratory support system and patient needs.