510(k) · Cleared
ClearediPEP System and vPEP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D R Burton Healthcare, LLC · BWF Spirometer, Therapeutic (Incentive)
Cleared on Aug 3, 2016 as substantially equivalent to K991561 (Dhd Healthcare Corp., 1999) and 2 other predicates after a 149-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Aug 3, 2016
- Review
- 149 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K954492 (1996). 9 ancestors in all, the oldest K940986 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK954492 Mercury Medical Expiratory Resistance Exerciser, ResistexMercury Medical · 1996
- 2 generations backK983467 TherapepDhd Healthcare Corp. · 1999
- 1 generation backK991561 Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999
- This deviceK160636 iPEP System and vPEPD R Burton Healthcare, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954492 | Mercury Medical Expiratory Resistance Exerciser, Resistex | Mercury Medical | 1996 | — |
| −2 | K983467 | Therapep | Dhd Healthcare Corp. | 1999 | — |
| −1 | K991561 | Roadrunner, Pep Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| 0 (this device) | K160636 | iPEP System and vPEP | D R Burton Healthcare, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K991561 | Roadrunner, Pep Therapy DeviceSummary page 4…, Class II Classification / CFR: 21CFR 868.5690 Device: iPEP System and vPEP Predicate Devices: K991561 – Roadrunner PEP Device (DHD Healthcare Corp.) K002768 – Acapella (DHD Healthcare Corp.)… | 1999 |
| * | K002768 | AcapellaSummary page 4…iPEP System and vPEP Predicate Devices: K991561 – Roadrunner PEP Device (DHD Healthcare Corp.) K002768 – Acapella (DHD Healthcare Corp.) K003146 – Cliniflo Incentive Spirometer (DHD Healthcare… | 2000 |
| * | K003146 | Cliniflo Incentive SpirometerSummary page 4…– Roadrunner PEP Device (DHD Healthcare Corp.) K002768 – Acapella (DHD Healthcare Corp.) K003146 – Cliniflo Incentive Spirometer (DHD Healthcare Corp.) Device Description: D R Burton Healthcare as indicated above proposes to… | 2000 |
| † | K123400 | Aerobika Positive Expiratory Pressure Device | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K991561.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 D R Burton iPEP Therapy System or vPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds and an Incentive Spirometer as an inspiratory, deep breathing positive exerciser.
Intended for single-patient, multi-use.
iPEP System for hospital and clinical settings
vPEP for hospital, clinical, and home care setting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160636: iPEP System and vPEP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160636
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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