# K080063: Mass Casualty Ventilator, Model MCV100

- Pathway: 510(k) (Traditional)
- Applicant: Allied Healthcare Products, Inc.
- Decided: Aug 15, 2008 after 218 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MCV1 00 and MCVl 00-B are intended to be used as an electrically controlled, electrical / gas powered emergency ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway.

Source page: https://510kreport.com/device/K080063
Methodology: https://510kreport.com/methodology