# K905697: Powered Ventilator, Lever I/II, Battlefield Use

- Pathway: 510(k) (Traditional)
- Applicant: Impact Instrumentation, Inc.
- Decided: Dec 27, 1990 after 3 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.
2 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021841: Comppac Ventilator Models 200 & PS11 Power Supply/Charger (2003), 1 descendant of its own
- K040090: Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains) (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K905697
Methodology: https://510kreport.com/methodology