# K040090: Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains)

- Pathway: 510(k) (Traditional)
- Applicant: Pneupac, Ltd.
- Decided: May 27, 2004 after 132 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: 2 generations back to K905697 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021841: Comppac Ventilator Models 200 & PS11 Power Supply/Charger, Pneupac, Ltd. (2003)

## Cited in the summary but kept off the family tree
- K020069: Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System, Medtronic Midas Rex (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Pneupac compPAC 200HD ventilator is a self contained portable gas powered automatic gas ventilator intended to provide ventilation to patients who have respiratory ditress or insufficiency. The comPAC 200HD is suitable for emergency and transport use for adult and paediatric patients greater than 20Kg in situations where convential portable ventilators may not be suitable

Source page: https://510kreport.com/device/K040090
Methodology: https://510kreport.com/methodology