PARAPAC 200 MEDIC - P200

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

510(k) Number

K020899 ↗

FDA Product Code

BTL

Models / Variants

P200

Parapac 200D Medic

Model P200D

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 Parapac 200 Medic ventilator used for?

  The Parapac 200 Medic is a portable, gas-powered ventilator designed for emergency situations. It operates solely on supply gas pressure and is classified as a Ventilator, Emergency, Powered (resuscitator), making it suitable for emergency medical use where traditional power sources may not be available.

• How is the Parapac 200 Medic ventilator supplied and what are its models?

  The Parapac 200 Medic is available in two models: P200 and P200D. It is manufactured by Pneupac, Ltd. and is supplied as a complete ventilator unit designed for emergency use. The device is gas-powered and does not require external electrical power sources for operation.

• What is the regulatory status of the Parapac 200 Medic ventilator?

  The Parapac 200 Medic ventilator is authorized under FDA 510(k) clearance with product code BTL. It is classified as Class II - Special Controls and is intended for use in the medical specialty of Anesthesiology. The device is regulated under regulation number 868.5925.

• How does the Parapac 200 Medic ventilator operate?

  The Parapac 200 Medic is a time-cycled ventilator that depends solely on the pressure of the supply gas for its operation. It does not require electrical power, making it particularly useful in emergency situations where traditional power sources may be unavailable or unreliable.