510(k) · Cleared
ClearedAerobika Positive Expiratory Pressure Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trudell Medical Intl. · BWF Spirometer, Therapeutic (Incentive)
Cleared on May 16, 2013 as substantially equivalent to K002768 (Dhd Healthcare Corp., 2000) after a 192-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- May 16, 2013
- Review
- 192 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002768 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002768 AcapellaDhd Healthcare Corp. · 2000 · Recalled
- This deviceK123400 Aerobika Positive Expiratory Pressure DeviceTrudell Medical Intl. · 2013
- Descendant · cites it directly · 1 of its ownK150173 Aerobika OPEP Devive with ManometerTrudell Medical International · 2015
- Descendant · 2 generations on · 0 of its ownK183108 Combined Aerobika OPEP and VersaPAP deviceTrudell Medical International · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002768 | Acapella | Dhd Healthcare Corp. | 2000 | 1 |
| 0 (this device) | K123400 | Aerobika Positive Expiratory Pressure Device | Trudell Medical Intl. | 2013 | — |
| +1 | K150173 | Aerobika OPEP Devive with Manometer | Trudell Medical International | 2015 | — |
| +2 | K183108 | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K002768 | AcapellaSummary page 1…BWF Classification Regulation 868.5690 Predicate Device 510(k) Number Trade/Model Name Manufacturer K002768 Acapella DHFD Healthcare Corp. Device Description The Aerobika* Oscillatin… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150173 | Aerobika OPEP Devive with Manometer | 2015 | 1 |
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. 2013, 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 Aeroblka* Oscillating Positive Expiratory Pressure device is Intended for use as a Positive Expiratory Pressure (PEP) device. The Aeroblka* 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 1pm for 3 -4 seconds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123400: Aerobika Positive Expiratory Pressure Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123400
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