# K140772: Aerosure Medic

- Pathway: 510(k) (Traditional)
- Applicant: Actegy, Ltd.
- Decided: Dec 19, 2014 after 267 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.
1 later device descends from it; 1 cites it directly.
0 of 11 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.
- K002768: Acapella, Dhd Healthcare Corp. (2000) Summary page 4.
- K991561: Roadrunner, Pep Therapy Device, Dhd Healthcare Corp. (1999) Summary page 4.

## Most influential descendants
- K203378: Pulsehaler (2021), 0 descendants of its own

## Indications for use
Aerosure is indicated for use as a Positive Expiratory Pressure (PEP) Device. • The use of Aerosure improves clearance of secretions • The use of Aerosure may reduce the need for postural drainage • Aerosure facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems • Aerosure may be used to prevent or reverse atelectasis • Aerosure may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis Aerosure is intended for patients age 21 and above with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis. All patients must be capable of following instructions for Positive Expiratory Pressure Therapy. Aerosure may be used in hospital as well as the home after a period of training.

Source page: https://510kreport.com/device/K140772
Methodology: https://510kreport.com/methodology