# K160636: iPEP System and vPEP

- Pathway: 510(k) (Traditional)
- Applicant: D R Burton Healthcare, LLC
- Decided: Aug 3, 2016 after 149 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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 4.
- K002768: Acapella, Dhd Healthcare Corp. (2000) Summary page 4.
- K003146: Cliniflo Incentive Spirometer, Dhd Healthcare Corp. (2000) Summary page 4.

## Indications for use
The D R Burton iPEP Therapy System or vPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds and an Incentive Spirometer as an inspiratory, deep breathing positive exerciser. Intended for single-patient, multi-use. iPEP System for hospital and clinical settings vPEP for hospital, clinical, and home care setting

Source page: https://510kreport.com/device/K160636
Methodology: https://510kreport.com/methodology