# K203209: AirPhysio Positive Expiratory Pressure (PEP) Device

- Pathway: 510(k) (Traditional)
- Applicant: Airphysio Pty, Ltd.
- Decided: Jan 15, 2021 after 77 days
- Product code: BYI (Percussor, Powered-Electric)
- Device class: 2
- Regulation: 21 CFR 868.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K940986 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972859: Flutter D, Bradstreet Clinical Research Assoc., Inc. (1998) Summary page 4.

## Most influential descendants
- K241091: SIMEOX 200 Airway Clearance Device (2024), 0 descendants of its own

## Indications for use
AirPhysio is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways. AirPhysio vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways. The device may also be useful in the removal of mucus from patients who have chronic bronchitis or bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.

Source page: https://510kreport.com/device/K203209
Methodology: https://510kreport.com/methodology