502 Resuscitatory Inhalator Valve

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

510(k) Number

K851337 ↗

FDA Product Code

BTL

Device Class

Class II

Regulation

21 CFR Part 868.5925

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

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• What clinical environments is the 502 Resuscitatory Inhalator Valve designed for use in?

  The 502 Resuscitatory Inhalator Valve is specifically intended for single-use in emergency settings where immediate ventilatory support is required. This includes clinical environments like emergency rooms, operating rooms, and pre-hospital scenarios, such as ambulances or first-responder deployments, where rapid resuscitation is critical.

• Is the 502 Resuscitatory Inhalator Valve reusable, and if not, what does that mean for its maintenance?

  No, the 502 Resuscitatory Inhalator Valve is designed for single-use only, meaning it is not meant to be cleaned, sterilized, or reused after a single procedure. This eliminates the need for maintenance or reprocessing, ensuring a sterile and reliable device for each emergency use.

• How is the device regulated, and what does its FDA clearance status imply for buyers?

  The 502 Resuscitatory Inhalator Valve holds FDA 510(k) clearance under the classification of Class II medical devices, governed by 21 CFR 868.5925 and the BTL product code. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meaning it meets established safety and performance standards for powered emergency ventilators. Buyers can rely on this regulatory pathway as assurance of its compliance with U.S. medical device regulations.

• What types of airway interfaces can the 502 Resuscitatory Inhalator Valve be used with?

  The device is designed to deliver emergency respiratory support via two primary interfaces: a face mask or an airway tube. This flexibility allows clinicians to adapt the valve to different patient needs, whether administering ventilation directly through a mask or via an established airway.

• How should the 502 Resuscitatory Inhalator Valve be stored, given its single-use nature?

  Since the device is intended for single-use only, it should be stored in its original packaging in a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. Proper storage ensures the device remains uncontaminated and ready for immediate use in emergency scenarios.