Mass Casualty Ventilators MCV200 and MCV200-B

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

Full name

Mass Casualty Ventilators, Models: MCV200 and MCV200-B

510(k) Number

K083385 ↗

FDA Product Code

BTL

Device Class

Class II

Regulation

21 CFR Part 868.5925

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Allied Healthcare Products, Inc. →

• What are the MCV200 and MCV200-B ventilators used for?

  These devices are powered emergency ventilators classified as resuscitators. They are specifically designed to provide mechanical ventilation support to patients in emergency settings.

• What is the regulatory status of these ventilators?

  The MCV200 and MCV200-B ventilators have received FDA 510(k) clearance. They are classified under regulation number 868.5925 within the anesthesiology medical specialty.

• Which medical specialty category do these ventilators fall under?

  These devices are categorized under the anesthesiology medical specialty, as indicated by the advisory committee classification and the associated regulation number for powered emergency ventilators.