# K801199: Voldyne Volumetric Incentive Deep BR. EX

- Pathway: 510(k) (Traditional)
- Applicant: Chesebrough-Pond'S U.S.A. Co.
- Decided: Jun 4, 1980 after 16 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.
2 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K141355: Volumetric Incentive Spirometer (2014), 1 descendant of its own
- K182847: Hudson RCI Voldyne Volumetric Exerciser (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K801199
Methodology: https://510kreport.com/methodology