VS Anesthesia Ventilator

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

510(k) Number

K790809 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

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 VS Anesthesia Ventilator designed for, and why is it classified as facility-use only?

  The VS Anesthesia Ventilator is specifically designed for use in controlled clinical environments like operating rooms or intensive care units where precise respiratory support is required during anesthesia procedures. It is classified as facility-use only because it is intended for continuous operation in a healthcare setting, requiring proper sterilization, maintenance, and adherence to institutional protocols—unlike portable or patient-use ventilators.

• How is the VS Anesthesia Ventilator supplied, and what does its reusable status mean for maintenance?

  The VS Anesthesia Ventilator is supplied as a reusable medical device, meaning it is not single-use. This requires strict adherence to the manufacturer’s sterilization and maintenance guidelines to ensure safety, functionality, and compliance with regulatory standards before each use in clinical settings.

• What regulatory pathway was followed for FDA clearance, and what does ‘Substantially Equivalent’ mean in this context?

  The VS Anesthesia Ventilator received FDA 510(k) clearance (K790809) in 1979 through the traditional review pathway under the Anesthesiology Advisory Committee. ‘Substantially Equivalent’ means the device was determined to have the same intended use and technological characteristics as legally marketed predicate devices, ensuring it meets safety and effectiveness standards without requiring new clinical trials.

• Are there any special handling instructions for storage or preparation before use?

  Since the VS Anesthesia Ventilator is reusable, it must be thoroughly sterilized and maintained per manufacturer guidelines before each use. While specific storage conditions aren’t detailed in the data, typical facility-use ventilators require clean, dry environments to prevent contamination and ensure longevity. Always follow the manufacturer’s instructions for optimal performance.