Patient Valve With Air Entrainment

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

510(k) Number

K863410 ↗

FDA Product Code

BTL

FDA applicant

Pneupac , Ltd.

Device Class

Class II

Regulation

21 CFR Part 868.5925

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 Patient Valve with Air Entrainment used for?

  It is designed for use in emergency ventilation scenarios as a ventilator, emergency, powered (resuscitator) and is indicated for use in anesthesiology settings, based on its 510(k) clearance.

• Is the Patient Valve with Air Entrainment reusable or single-use?

  The device is supplied as a reusable device, as stated in its specifications, meaning it can be cleaned and reused according to the manufacturer's instructions.

• What regulatory pathway was used for the Patient Valve with Air Entrainment?

  It received traditional 510(k) clearance (K863410) on January 12, 1987, following a 173-day review, and was found substantially equivalent to a predicate device.

• What is the product code and regulation number for this device?

  The device is classified under product code BTL and regulation number 868.5925, which defines it as a Ventilator, Emergency, Powered (Resuscitator) for FDA classification purposes.