Pneu Pac Ventilator/Resuscitators

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

510(k) Number

K832700 ↗

FDA Product Code

CBK

FDA applicant

Pneupac , Ltd.

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Pneupac Test Set, PT.#500-A250

  Class II

  FDA 510(k) K792458 Active Cleared 5 Feb 1980

• Compressor

  Class II

  FDA 510(k) K792457 Active Cleared 5 Feb 1980

• Models 2R and 3R Pneupac Ventilator/Resuscitator

  Class II

  FDA 510(k) K862830 Active Cleared 15 Oct 1986

• Pneupac Oxygen Therapy Unit

  Class II

  FDA 510(k) K792453 Active Cleared 5 Feb 1980

• Parapac

  Class II

  FDA 510(k) K960515 Active Cleared 10 Oct 1996

• Babypac

  Class II

  FDA 510(k) K970158 Active Cleared 28 Apr 1998

See all devices from Pneupac, Ltd. →

• What is the Pneu Pac Ventilator/Resuscitator designed for?

  The Pneu Pac Ventilator/Resuscitator is a facility-use ventilator intended for controlled respiratory support in critical care settings. It provides consistent oxygenation and ventilation for patients requiring mechanical assistance, such as those in hospital intensive care units or operating rooms. Its design adheres to FDA Class II standards, ensuring safety and efficacy for continuous use in clinical environments.

• Is the Pneu Pac Ventilator/Resuscitator sterile when delivered?

  No, the Pneu Pac Ventilator/Resuscitator is not sterile upon delivery. It is classified as a reusable device, meaning it requires thorough cleaning, maintenance, and sterilization between uses to maintain hygiene and functionality. Proper sterilization procedures are essential to prevent cross-contamination in facility-based settings.

• How is the Pneu Pac Ventilator/Resuscitator regulated?

  The Pneu Pac Ventilator/Resuscitator is regulated under the FDA’s 510(k) clearance process, specifically under product code CBK for continuous-use ventilators. It was reviewed by the Anesthesiology advisory committee and granted clearance as substantially equivalent to a predicate device. The device complies with FDA regulation 868.5895, ensuring it meets established safety and performance standards for facility-based use.

• What types of facilities can use the Pneu Pac Ventilator/Resuscitator?

  The Pneu Pac Ventilator/Resuscitator is designed exclusively for facility-based environments, such as hospitals, clinics, or surgical centers. Its reusable nature and robust design make it suitable for continuous use in critical care units, operating rooms, or emergency departments where mechanical ventilation support is required. It is not intended for home or portable use.

• What maintenance or cleaning procedures are required for this ventilator?

  Since the Pneu Pac Ventilator/Resuscitator is reusable, it must undergo strict cleaning, maintenance, and sterilization protocols between patient uses. Manufacturer guidelines should be followed to ensure proper disinfection and inspection of components. Regular servicing by trained personnel is recommended to uphold performance, safety, and compliance with regulatory standards for reusable medical devices.