510(k) · Cleared
ClearedThe Breather
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pal Medical, Inc. · BWF Spirometer, Therapeutic (Incentive)
Cleared on Apr 26, 1995 after a 230-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 26, 1995
- Review
- 230 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK944412 The BreatherPal Medical, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK974848 Mini-CiserHougen Mfg., Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK992256 Frolov's Respiration Training Device, FRTD-01Intercontinental New Technologies, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK974849 X-Air-CiserHougen Mfg., Inc. · 1998
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944412 | The Breather | Pal Medical, Inc. | 1995 | — |
| +1 | K974848 | Mini-Ciser | Hougen Mfg., Inc. | 1998 | — |
| +2 | K992256 | Frolov's Respiration Training Device, FRTD-01 | Intercontinental New Technologies, Inc. | 2000 | — |
| +1 | K974849 | X-Air-Ciser | Hougen Mfg., Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K974848 (Hougen Mfg., Inc., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K944412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944412: The Breather.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944412
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026