510(k) · Cleared
ClearedAerosure Medic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actegy, Ltd. · BWF Spirometer, Therapeutic (Incentive)
Cleared on Dec 19, 2014 as substantially equivalent to K972859 (Bradstreet Clinical Research Assoc., Inc., 1998) and 2 other predicates after a 267-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Dec 19, 2014
- Review
- 267 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K954492 (1996). 9 ancestors in all, the oldest K940986 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK954492 Mercury Medical Expiratory Resistance Exerciser, ResistexMercury Medical · 1996
- 2 generations backK983467 TherapepDhd Healthcare Corp. · 1999
- 1 generation backK991561 Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999
- This deviceK140772 Aerosure MedicActegy, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK203378 PulsehalerRespinova, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K203378PulsehalerRespinova, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954492 | Mercury Medical Expiratory Resistance Exerciser, Resistex | Mercury Medical | 1996 | — |
| −2 | K983467 | Therapep | Dhd Healthcare Corp. | 1999 | — |
| −1 | K991561 | Roadrunner, Pep Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| 0 (this device) | K140772 | Aerosure Medic | Actegy, Ltd. | 2014 | — |
| +1 | K203378 | Pulsehaler | Respinova, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BWF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BWF device
- #1 K241152 InSeescore 9.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972859 | Flutter DSummary page 4…e Incentive spirometer, 21 C.F.R. §868.5690, Product code BWF Powered percussor, 21 C.F.R. § 868.5665, Product code BYI Predicate Devices Flutter D (Clement Clarke), K972859; Acapella (Smiths Medical), K002768; Roadrunner (DHD), K991561. Intended Use / Indications for Use Aerosure is i… | 1998 |
| * | K002768 | AcapellaSummary page 4…868.5690, Product code BWF Powered percussor, 21 C.F.R. § 868.5665, Product code BYI Predicate Devices Flutter D (Clement Clarke), K972859; Acapella (Smiths Medical), K002768; Roadrunner (DHD), K991561. Intended Use / Indications for Use Aerosure is indicated for use as a Positive Expir… | 2000 |
| * | K991561 | Roadrunner, Pep Therapy DeviceSummary page 4…Powered percussor, 21 C.F.R. § 868.5665, Product code BYI Predicate Devices Flutter D (Clement Clarke), K972859; Acapella (Smiths Medical), K002768; Roadrunner (DHD), K991561. Intended Use / Indications for Use Aerosure is indicated for use as a Positive Expiratory Pressure (PEP) Device… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203378 | Pulsehaler | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K203378 (Respinova, Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K972859.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · BWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BWF
281in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BWF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BWF
3in 2025
MAUDE reports naming product code BWF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 39 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 19 |
| 2014 | 3 | 105 | 0 | 5 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 3 | 149 | 0 | 6 |
| 2017 | 3 | 136 | 0 | 7 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 3 | 281 | 0 | 16 |
| 2020 | 1 | — | 1 | 5 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (137 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140772 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140772: Aerosure Medic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140772
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026