# K181660: Acapella Choice Blue Vibratory PEP Device

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical
- Decided: Oct 24, 2019 after 486 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 K002768 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002768: Acapella, Dhd Healthcare Corp. (2000) Summary page 4.

## Indications for use
The Smiths Medical acapella® Choice Blue Vibratory PEP Device is intended for use as a Positive Expiratory Pressure (PEP) device for adults and children (5 years and up). It may also be used simultaneously with nebulized aerosol drug delivery.

Source page: https://510kreport.com/device/K181660
Methodology: https://510kreport.com/methodology