510(k) · Cleared
ClearedTherapep
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 Apr 2, 1999 as substantially equivalent to K954492 (Mercury Medical, 1996) after a 189-day review. Its family tree reaches back 1 generation to 1996. 7 later devices descend from it.
- Decided
- Apr 2, 1999
- Review
- 189 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954492 (1996). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954492 Mercury Medical Expiratory Resistance Exerciser, ResistexMercury Medical · 1996
- This deviceK983467 TherapepDhd Healthcare Corp. · 1999
- Descendant · cites it directly · 5 of its ownK991561 Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK140772 Aerosure MedicActegy, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK233855 AllPEPEnchant Tek Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK203378 PulsehalerRespinova, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK160636 iPEP System and vPEPD R Burton Healthcare, LLC · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K991561Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999 · cites it directly5descendants
- K140772Aerosure MedicActegy, Ltd. · 2014 · 2 generations on1descendant
- K233855AllPEPEnchant Tek Co., Ltd. · 2024 · 2 generations on0descendants
- K203378PulsehalerRespinova, Ltd. · 2021 · 3 generations on0descendants
- K160636iPEP System and vPEPD R Burton Healthcare, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954492 | Mercury Medical Expiratory Resistance Exerciser, Resistex | Mercury Medical | 1996 | — |
| 0 (this device) | K983467 | Therapep | Dhd Healthcare Corp. | 1999 | — |
| +1 | K991561 | Roadrunner, Pep Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| +2 | K140772 | Aerosure Medic | Actegy, Ltd. | 2014 | — |
| +2 | K233855 | AllPEP | Enchant Tek Co., Ltd. | 2024 | — |
| +3 | K203378 | Pulsehaler | Respinova, Ltd. | 2021 | — |
| +2 | K160636 | iPEP System and vPEP | D R Burton Healthcare, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K954492 | Mercury Medical Expiratory Resistance Exerciser, ResistexSummary page 1…® Kits . Common name - Positive Expiratory Pressure (PEP) Kit with Nebulizer . Classification name - Incentive Spirometer - 868.5690 Predicate Device: RESISTEX® 510(K) k954492 Device Description The DHD TheraPEP® is a single-patient-use Respiratory Therapy device. The standard system consists of a resis… | 1996 |
| † | K953206 | DHD Metered Dose Inhaler (Mdi) Spacer (Modification) | 1995 |
What descends from it? (7)
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?
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 (PEP) device. It may also be used simultaneously with aerosol drug delivery using a nebulizer or Metered Dose Inhaler (MDI) with spacer.
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/K983467 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983467: Therapep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983467
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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