# K002768: Acapella

- Pathway: 510(k) (Traditional)
- Applicant: Dhd Healthcare Corp.
- Decided: Dec 5, 2000 after 90 days
- Product code: BWF (Spirometer, Therapeutic (Incentive))
- Device class: 2
- Regulation: 21 CFR 868.5690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 7 cite it directly.
2 of 16 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
- K132988: Vital Cough (2014), 5 descendants of its own
- K192143: Maximus System (2020), 4 descendants of its own
- K200988: Maximus System (2020), 3 descendants of its own
- K123400: Aerobika  Positive Expiratory Pressure Device (2013), 2 descendants of its own
- K231728: BiWaze Clear System (2024), 1 descendant of its own

## Recalls of this device
- Dec 21, 2020 · Class II · Z-0874-2021: Shipping box may contain wrong model.

Source page: https://510kreport.com/device/K002768
Methodology: https://510kreport.com/methodology