# K021841: Comppac Ventilator Models 200 & PS11 Power Supply/Charger

- Pathway: 510(k) (Traditional)
- Applicant: Pneupac, Ltd.
- Decided: Jul 17, 2003 after 407 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
Longest line of descent: 1 generation back to K905697 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905697: Powered Ventilator, Lever I/II, Battlefield Use, Impact Instrumentation, Inc. (1990) Summary page 1.

## Most influential descendants
- K040090: Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains) (2004), 0 descendants of its own

## Indications for use
The Pneupac compPAC 200 ventilator is a self contained portable gas powered automatic ventilator intended to provide emergency ventilation, in a battlefield environment only, to adult and pediatric patients greater than 20 kg. The compPAC 200 is suitable for emergency and transport use in situations where conventional portable ventilators are not suitable.

Source page: https://510kreport.com/device/K021841
Methodology: https://510kreport.com/methodology