510(k) · Cleared
ClearedTherapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask, Resistor/Port/Mouthpiece, Resistor/Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diemolding Corp. · BWF Spirometer, Therapeutic (Incentive)
Cleared on Oct 10, 1996 after an 87-day review. The FDA summary names its predicate without a number. 2 of the 20 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it.
- Decided
- Oct 10, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 3 citing it directly. 2 of the 20 devices in this family, counting this one, have a Class I recall.
- This deviceK962749 Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask…Diemolding Corp. · 1996
- Descendant · cites it directly · 11 of its ownK991300 Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999
- Descendant · 2 generations on · 7 of its ownK051964 PowernebComedica, Inc. · 2005
- Descendant · 3 generations on · 6 of its ownK124032 MetanebHill-Rom Services Pte, Ltd. · 2013
- Descendant · 3 generations on · 5 of its ownK151689 MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016
- Descendant · cites it directly · 5 of its ownK991561 Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 19 · See all- K991300Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999 · cites it directly11descendants
- K051964PowernebComedica, Inc. · 2005 · 2 generations on7descendants
- K124032MetanebHill-Rom Services Pte, Ltd. · 2013 · 3 generations on6descendants
- K151689MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016 · 3 generations on5descendants
- K991561Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962749 | Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask… | Diemolding Corp. | 1996 | — |
| +1 | K991300 | Boeing, Positive Airway Pressure (Pap) Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| +2 | K051964 | Powerneb | Comedica, Inc. | 2005 | — |
| +3 | K124032 | Metaneb | Hill-Rom Services Pte, Ltd. | 2013 | — |
| +3 | K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016 | — |
| +1 | K991561 | Roadrunner, Pep Therapy Device | Dhd Healthcare Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 2 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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.
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? (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 |
|---|---|---|---|
| * | — | DHD TheraPEP Named without a submission number |
What descends from it? (19)
See all 193 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)
No FDA recall names this device.
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, K991300 (Dhd Healthcare Corp., 1999) has gone furthest, with 11 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 | — |
What is it indicated for?
The DHD TheraPEP is intended for use as a Positive Expiratory Pressure Device for patients suffering from Cystic Fibrosis, lung diseases with secretory problems, and to prevent or reverse atelectasis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962749 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962749: Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask, Resistor/Port/Mouthpiece, Resistor/Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962749
Report an extraction error
Are you the manufacturer?
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