510(k) · Cleared
Recalled · Class II · 2020Acapella
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dhd Healthcare Corp. · BWF Spirometer, Therapeutic (Incentive)
Cleared on Dec 5, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 16 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it. It has been recalled once.
- Decided
- Dec 5, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- BWF
- Recalls
- 1
- Predicates
- 0
15 later devices descend from it, 7 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- This deviceK002768 AcapellaDhd Healthcare Corp. · 2000
- Descendant · cites it directly · 5 of its ownK132988 Vital CoughLung Assist, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK192143 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK200988 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK123400 Aerobika Positive Expiratory Pressure DeviceTrudell Medical Intl. · 2013
- Descendant · 4 generations on · 1 of its ownK231728 BiWaze Clear SystemAbmrc, LLC · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K132988Vital CoughLung Assist, Inc. · 2014 · cites it directly5descendants
- K192143Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · 2 generations on4descendants
- K200988Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · 3 generations on3descendants
- K123400Aerobika Positive Expiratory Pressure DeviceTrudell Medical Intl. · 2013 · cites it directly2descendants
- K231728BiWaze Clear SystemAbmrc, LLC · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002768 | Acapella | Dhd Healthcare Corp. | 2000 | — |
| +1 | K132988 | Vital Cough | Lung Assist, Inc. | 2014 | — |
| +2 | K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| +3 | K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| +1 | K123400 | Aerobika Positive Expiratory Pressure Device | Trudell Medical Intl. | 2013 | — |
| +4 | K231728 | BiWaze Clear System | Abmrc, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 2 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
2 devices in this family have a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 157 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2020 | Class II | Z-0874-2021 | Nonconforming Material/Component | Shipping box may contain wrong model. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K132988 (Lung Assist, Inc., 2014) has gone furthest, with 5 descendants 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/K002768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002768: Acapella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002768
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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