510(k) · Cleared
ClearedAerobika OPEP Devive with Manometer
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 Oct 15, 2015 as substantially equivalent to K123400 (Trudell Medical Intl., 2013) after a 262-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Oct 15, 2015
- Review
- 262 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002768 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002768 AcapellaDhd Healthcare Corp. · 2000 · Recalled
- 1 generation backK123400 Aerobika Positive Expiratory Pressure DeviceTrudell Medical Intl. · 2013
- This deviceK150173 Aerobika OPEP Devive with ManometerTrudell Medical International · 2015
- Descendant · cites it directly · 0 of its ownK183108 Combined Aerobika OPEP and VersaPAP deviceTrudell Medical International · 2019
Most influential descendants
Showing 1 of 1 · See all- K183108Combined Aerobika OPEP and VersaPAP deviceTrudell Medical International · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002768 | Acapella | Dhd Healthcare Corp. | 2000 | 1 |
| −1 | K123400 | Aerobika Positive Expiratory Pressure Device | Trudell Medical Intl. | 2013 | — |
| 0 (this device) | K150173 | Aerobika OPEP Devive with Manometer | Trudell Medical International | 2015 | — |
| +1 | K183108 | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K123400 | Aerobika Positive Expiratory Pressure DeviceSummary page 4…national’s Aerobika* OPEP device, which was classified under product code BWF, regulation 868.5690, Incentive Spirometer, and cleared on May 16, 2013 under 510(k) number K123400. The predicate Aerobika* OPEP device was found to be substantially equivalent to DHD Healthcare Corp’s Acapella Spirometer, 510(k… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183108 | Combined Aerobika OPEP and VersaPAP device | 2019 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K183108 (Trudell Medical International, 2019) has gone furthest, with 0 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. 2015, 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 Aerobika* Oscillating Positive Expiratory Pressure device is intended for use as a Positive Expiratory Pressure (PEP) device. The Aerobika* Oscillating PEP device may also be used simultaneously with nebulized aerosol drug delivery. The device is intended to be used by patients capable of generating an exhalation flow of 10 Ipm for 3 - 4 seconds.
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/K150173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150173: Aerobika OPEP Devive with Manometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150173
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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