# K944412: The Breather

- Pathway: 510(k) (Traditional)
- Applicant: Pal Medical, Inc.
- Decided: Apr 26, 1995 after 230 days
- Product code: BWF (Spirometer, Therapeutic (Incentive))
- Device class: 2
- Regulation: 21 CFR 868.5690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K974848: Mini-Ciser (1998), 1 descendant of its own
- K992256: Frolov's Respiration Training Device, FRTD-01 (2000), 0 descendants of its own
- K974849: X-Air-Ciser (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K944412
Methodology: https://510kreport.com/methodology