# K974849: X-Air-Ciser

- Pathway: 510(k) (Traditional)
- Applicant: Hougen Mfg., Inc.
- Decided: Aug 6, 1998 after 220 days
- Product code: BYI (Percussor, Powered-Electric)
- Device class: 2
- Regulation: 21 CFR 868.5665
- 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 K944412 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944412: The Breather, Pal Medical, Inc. (1995) Summary page 1.

## Indications for use
The X-Air-Ciser is a Positive Expiratory Pressure (PEP) device, Inspiratory Muscle Trainer (IMT) and Percussor all in one device. The X-Air-Ciser can also function as a percussor, that may be helpful loosening and removing mucus. Patient population: Adult & Children, Single patient use and reusable.

Source page: https://510kreport.com/device/K974849
Methodology: https://510kreport.com/methodology