510(k) · Cleared
ClearedTrachFlush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aw Technologies Aps · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Aug 13, 2026 as substantially equivalent to K220854 (Aw Technologies Aps, 2023) after a 99-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Aug 13, 2026
- Review
- 99 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K912723 (1991). 8 ancestors in all, the oldest K791045 (1979). No later device cites it as a predicate yet.
- Root · 5 generations backK912723 Posey CufflatorPosey Co. · 1991
- 4 generations backK081805 CuffalertSunmed · 2008
- 3 generations backK092733 PYTONArm Medical Devices, Inc. · 2010
- 2 generations backK150893 IntelliCuffHamilton Medical AG · 2016 · Recalled
- 1 generation backK220854 TrachCuff Cuff ControllerAw Technologies Aps · 2023
- This deviceK261499 TrachFlushAw Technologies Aps · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912723 | Posey Cufflator | Posey Co. | 1991 | — |
| −4 | K081805 | Cuffalert | Sunmed | 2008 | — |
| −3 | K092733 | PYTON | Arm Medical Devices, Inc. | 2010 | — |
| −2 | K150893 | IntelliCuff | Hamilton Medical AG | 2016 | 2 |
| −1 | K220854 | TrachCuff Cuff Controller | Aw Technologies Aps | 2023 | — |
| 0 (this device) | K261499 | TrachFlush | Aw Technologies Aps | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 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 BSK? 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 BSK device
- #1 K243562 CuffGuardscore 10.7 · 4 generations · 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.
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 35 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · BSK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSK
376in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSK
1in 2017
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSK
46in 2025
MAUDE reports naming product code BSK, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 3 | 171 | 0 | 15 |
| 2012 | 2 | — | 0 | 62 |
| 2013 | 1 | — | 1 (1) | 16 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 4 | 376 | 0 | 1 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 51 |
| 2024 | 0 | — | 0 | 133 |
| 2025 | 2 | — | 0 | 46 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The TrachFlush device is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation.
The TrachFlush device is also intended to assist in clearing upper airway secretions by simulating an artificial cough during mechanical ventilation.
The TrachFlush device can be used with any mechanical ventilator.
The TrachFlush device is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT, in the following areas:
• In the intensive care ward by Respiratory Therapist
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261499: TrachFlush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261499
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026