510(k) · Cleared
ClearedRoadrunner, Pep Therapy Device
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 Nov 10, 1999 as substantially equivalent to K944900 (Dhd Diemolding Healthcare Div., 1995) and 4 other predicates after a 190-day review. Its family tree reaches back 2 generations to 1996. 5 later devices descend from it.
- Decided
- Nov 10, 1999
- Review
- 190 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K954492 (1996). 6 ancestors in all, the oldest K940986 (1994). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK954492 Mercury Medical Expiratory Resistance Exerciser, ResistexMercury Medical · 1996
- 1 generation backK983467 TherapepDhd Healthcare Corp. · 1999
- This deviceK991561 Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999
- Descendant · cites it directly · 1 of its ownK140772 Aerosure MedicActegy, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK233855 AllPEPEnchant Tek Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK203378 PulsehalerRespinova, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK160636 iPEP System and vPEPD R Burton Healthcare, LLC · 2016
- Descendant · cites it directly · 0 of its ownK133057 Vibralung Acoustical PercussorWestmed, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K140772Aerosure MedicActegy, Ltd. · 2014 · cites it directly1descendant
- K233855AllPEPEnchant Tek Co., Ltd. · 2024 · cites it directly0descendants
- K203378PulsehalerRespinova, Ltd. · 2021 · 2 generations on0descendants
- K160636iPEP System and vPEPD R Burton Healthcare, LLC · 2016 · cites it directly0descendants
- K133057Vibralung Acoustical PercussorWestmed, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954492 | Mercury Medical Expiratory Resistance Exerciser, Resistex | Mercury Medical | 1996 | — |
| −1 | K983467 | Therapep | Dhd Healthcare Corp. | 1999 | — |
| 0 (this device) | K991561 | Roadrunner, Pep Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| +1 | K140772 | Aerosure Medic | Actegy, Ltd. | 2014 | — |
| +1 | K233855 | AllPEP | Enchant Tek Co., Ltd. | 2024 | — |
| +2 | K203378 | Pulsehaler | Respinova, Ltd. | 2021 | — |
| +1 | K160636 | iPEP System and vPEP | D R Burton Healthcare, LLC | 2016 | — |
| +1 | K133057 | Vibralung Acoustical Percussor | Westmed, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K944900 | TherapepSummary page 1…ined Common Name: Positive Expiratory Pressure (PEP) Device Classification Name: Incentive Spirometer — 868.5690 Predicate Devices: TheraPEP® O : Flutter® ® : K946083 K944900, K962749, K983467 K940986, K946083 DHD Healthcare Scandipharm Incorporated 125 Rasbach Street 22 Inverness Center Pkwy Canastot… | 1995 |
| * | K962749 | Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask…Summary page 1…mon Name: Positive Expiratory Pressure (PEP) Device Classification Name: Incentive Spirometer — 868.5690 Predicate Devices: TheraPEP® O : Flutter® ® : K946083 K944900, K962749, K983467 K940986, K946083 DHD Healthcare Scandipharm Incorporated 125 Rasbach Street 22 Inverness Center Pkwy Canastota NY 1303… | 1996 |
| * | K983467 | TherapepSummary page 1…Positive Expiratory Pressure (PEP) Device Classification Name: Incentive Spirometer — 868.5690 Predicate Devices: TheraPEP® O : Flutter® ® : K946083 K944900, K962749, K983467 K940986, K946083 DHD Healthcare Scandipharm Incorporated 125 Rasbach Street 22 Inverness Center Pkwy Canastota NY 13032 Birming… | 1999 |
| * | K940986 | Flutter (R)Summary page 1…e Expiratory Pressure (PEP) Device Classification Name: Incentive Spirometer — 868.5690 Predicate Devices: TheraPEP® O : Flutter® ® : K946083 K944900, K962749, K983467 K940986, K946083 DHD Healthcare Scandipharm Incorporated 125 Rasbach Street 22 Inverness Center Pkwy Canastota NY 13032 Birmingham, Ala… | 1994 |
| * | K946083 | Flutter (R)Summary page 1…Be Determined Common Name: Positive Expiratory Pressure (PEP) Device Classification Name: Incentive Spirometer — 868.5690 Predicate Devices: TheraPEP® O : Flutter® ® : K946083 K944900, K962749, K983467 K940986, K946083 DHD Healthcare Scandipharm Incorporated 125 Rasbach Street 22 Inverness Center Pkwy… | 1995 |
What descends from it? (5)
4 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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K140772 (Actegy, Ltd., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K944900.
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?
1 - Purpose: The DHD Roadrunner is indicated for use as a Positive Expiratory Pressure (PEP) Device. 2 - Claims: = The use of DHD Roadrunner improves clearance of secretions » The use of DHD Roadrunner may reduce the need for postural drainage * DHD Roadrunner facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems = The DHD Roadrunner may be used to prevent or reverse atelectasis 3 -…
Read the full statement (152 words)
1 - Purpose:
The DHD Roadrunner is indicated for use as a Positive Expiratory Pressure (PEP) Device.
2 - Claims:
= The use of DHD Roadrunner improves clearance of secretions
» The use of DHD Roadrunner may reduce the need for postural drainage
* DHD Roadrunner facilitates opening of airways in patients with Cystic Fibrosis, COPD,
asthma, and lung diseases with secretory problems
= The DHD Roadrunner may be used to prevent or reverse atelectasis
3 - Target Patient Population
Patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and
patients with atelectasis. All patients must be capable of following instructions for Positive
Expiratory Pressure Therapy.
4 - Intended Environment For Use
= Labeling reflects the statement: “Federal (USA) Law restricts this device to sale by or on the
order of a physician.”
= May be used in hospital as well as the home after a period of training.
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/K991561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991561: Roadrunner, Pep Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991561
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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