510(k) · Cleared
ClearedCombined Aerobika OPEP and VersaPAP device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trudell Medical International · BWF Spirometer, Therapeutic (Incentive)
Cleared on Aug 16, 2019 as substantially equivalent to K150173 (Trudell Medical International, 2015) and 1 other predicate after a 281-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 16, 2019
- Review
- 281 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002768 (2000). 7 ancestors in all, the oldest K944900 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK002768 AcapellaDhd Healthcare Corp. · 2000 · Recalled
- 2 generations backK123400 Aerobika Positive Expiratory Pressure DeviceTrudell Medical Intl. · 2013
- 1 generation backK150173 Aerobika OPEP Devive with ManometerTrudell Medical International · 2015
- This deviceK183108 Combined Aerobika OPEP and VersaPAP deviceTrudell Medical International · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002768 | Acapella | Dhd Healthcare Corp. | 2000 | 1 |
| −2 | K123400 | Aerobika Positive Expiratory Pressure Device | Trudell Medical Intl. | 2013 | — |
| −1 | K150173 | Aerobika OPEP Devive with Manometer | Trudell Medical International | 2015 | — |
| 0 (this device) | K183108 | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K150173 | Aerobika OPEP Devive with ManometerSummary page 4…Code/Name: BWF – Incentive Spirometer 21 CFR 868.5690 Class II Predicate Devices: K150173 – Trudell – Aerobika® OPEP K173918 – Trudell – VersaPAP™ device Reference Device:… | 2015 |
| * | K173918 | VersaPAP Positive Airway Pressure (PAP) DeviceSummary page 4…21 CFR 868.5690 Class II Predicate Devices: K150173 – Trudell – Aerobika® OPEP K173918 – Trudell – VersaPAP™ device Reference Device: K151689 – Hill-Rom – MetaNeb® Device Description: The Aerobika® OP… | 2018 |
| † | K151689 | MetaNeb 4 System | 2016 |
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 19 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Combined VersaPAP™ and Aerobika® OPEP device is intended for use as a Positive Airway Pressure (PAP) device and a Positive Expiratory Pressure (PEP) device. The combined device has the ability to provide supplemental oxygen when used with compressed oxygen. The combined device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway Pressure Therapy and capable of generating exhalation flow of 10 lpm for 3 – 4 seconds. The combined device is a single patient, multiple use device intended to be used in a hospital environment under the supervision of a healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183108: Combined Aerobika OPEP and VersaPAP device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183108
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