Pneupac Ventilator/Resuscitator #2

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

510(k) Number

K792455 ↗

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 Pneupac Ventilator/Resuscitator #2 used for?

  The Pneupac Ventilator/Resuscitator #2 is a continuous ventilator designed specifically for facility use, providing mechanical ventilation support in clinical settings.

• What is the regulatory status of the Pneupac Ventilator/Resuscitator #2?

  This device is classified as a Class II medical device under product code CBK with special controls and received FDA 510(k) clearance on February 5, 1980, with the K number K792455.

• Is the Pneupac Ventilator/Resuscitator #2 reusable or single-use?

  The device data does not specify whether the Pneupac Ventilator/Resuscitator #2 is designed for single-use or multiple uses, as this information is not provided in the regulatory documentation.

• What sizes or models of the Pneupac Ventilator/Resuscitator #2 are available?

  The device data does not provide information about different sizes or models of the Pneupac Ventilator/Resuscitator #2, only that it is a continuous ventilator designed for facility use.

• How should the Pneupac Ventilator/Resuscitator #2 be stored?

  The device data does not specify storage requirements for the Pneupac Ventilator/Resuscitator #2, as this information is not included in the regulatory documentation provided.