# K922654: Ventilator Adult Star Modification

- Pathway: 510(k) (Traditional)
- Applicant: Infrasonics Corp.
- Decided: Dec 1, 1992 after 181 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K063650: Ventilator with Respiratory Mechanics, Model 840 (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K922654
Methodology: https://510kreport.com/methodology