# K974848: Mini-Ciser

- Pathway: 510(k) (Traditional)
- Applicant: Hougen Mfg., Inc.
- Decided: Aug 6, 1998 after 220 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
Longest line of descent: 1 generation back to K944412 (1995). 1 ancestor in all.
1 later device descends 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)
- K944412: The Breather, Pal Medical, Inc. (1995) Summary page 1.

## Most influential descendants
- K992256: Frolov's Respiration Training Device, FRTD-01 (2000), 0 descendants of its own

## Indications for use
The Mini-Ciser is a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in onc device. The Mini-Ciser may be helpful in Joosening and removal of mucus. Patient population: Adult & Children. Single patient use and reusable. Caution: Federal law restricts this dcvice to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K974848
Methodology: https://510kreport.com/methodology