# K141355: Volumetric Incentive Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Besmed Health Business Corporation
- Decided: Sep 3, 2014 after 103 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 K801199 (1980). 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)
- K801199: Voldyne Volumetric Incentive Deep BR. EX, Chesebrough-Pond'S U.S.A. Co. (1980) Summary page 4.

## Most influential descendants
- K182847: Hudson RCI Voldyne Volumetric Exerciser (2019), 0 descendants of its own

## Indications for use
The Besmed Volumetric 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/K141355
Methodology: https://510kreport.com/methodology