510(k) · Cleared
ClearedPulsehaler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respinova, Ltd. · BWF Spirometer, Therapeutic (Incentive)
Cleared on Mar 31, 2021 as substantially equivalent to K140772 (Actegy, Ltd., 2014) after a 134-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Mar 31, 2021
- Review
- 134 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954492 (1996). 10 ancestors in all, the oldest K940986 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK954492 Mercury Medical Expiratory Resistance Exerciser, ResistexMercury Medical · 1996
- 3 generations backK983467 TherapepDhd Healthcare Corp. · 1999
- 2 generations backK991561 Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999
- 1 generation backK140772 Aerosure MedicActegy, Ltd. · 2014
- This deviceK203378 PulsehalerRespinova, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954492 | Mercury Medical Expiratory Resistance Exerciser, Resistex | Mercury Medical | 1996 | — |
| −3 | K983467 | Therapep | Dhd Healthcare Corp. | 1999 | — |
| −2 | K991561 | Roadrunner, Pep Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| −1 | K140772 | Aerosure Medic | Actegy, Ltd. | 2014 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K140772 | Aerosure MedicSummary page 4…™ Device Classification and Product Code Spirometer, Therapeutic (Incentive), 21 CFR 868.5690, Class II, BWF Predicate Devices Actegy - Aerosure Medic (K140772, Predicate Device) Trudell Medical - Aerobika (K123400, Reference Device) Indications for Use Pulsehaler™ is indicated… | 2014 |
| † | K123400 | Aerobika Positive Expiratory Pressure Device | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 2 of the 10 ancestors have a recall of any class.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Pulsehaler™ is indicated for use as a Positive Expiratory Pressure (PEP) Device.
• The use of Pulsehaler™ improves clearance of secretions
• The use of Pulsehaler™ may reduce the need for postural drainage
• Pulsehaler™ facilitates opening of airways in patients
• Pulsehaler™ may be used to prevent or reverse atelectasis
• Pulsehaler™ may also be useful in the removal of mucus from the lungs
Pulsehaler™ is intended for single patient, adult users in a home or hospital environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203378 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203378: Pulsehaler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203378
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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