# K233855: AllPEP

- Pathway: 510(k) (Traditional)
- Applicant: Enchant Tek Co., Ltd.
- Decided: Feb 2, 2024 after 59 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: 3 generations back to K954492 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991561: Roadrunner, Pep Therapy Device, Dhd Healthcare Corp. (1999) Summary page 5.

## Indications for use
The Enchant AllPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients aged 18 years and older. Patients must be capable of generating an exhalation flow of 10 lpm for 3-4 seconds to promote secretion clearance. This device may be used to prevent or reverse atelectasis and as an inspiratory, deep breathing positive exerciser. It may be used in hospital and clinical settings.

Source page: https://510kreport.com/device/K233855
Methodology: https://510kreport.com/methodology