# K133873: Triball Incentive Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Besmed Health Business Corp
- Decided: Apr 4, 2014 after 105 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 K781831 (1978). 1 ancestor in all.
2 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)
- K781831: Spirometer, Incentive Catalog # 1750, Hudson Oxygen Therapy Sales Co. (1978) Summary page 1.

## Most influential descendants
- K220565: Hudson RCI Triflo II Incentive Deep Breathing Exerciser (2022), 0 descendants of its own
- K160837: Medinet Incentive Spirometers - Respiprogram (2017), 0 descendants of its own

## Indications for use
The Besmed Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser. Intended for single-patient, multi-use in a hospital or home care setting.

Source page: https://510kreport.com/device/K133873
Methodology: https://510kreport.com/methodology