510(k) · Cleared
ClearedTrachCuff Cuff Controller
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 Apr 14, 2023 as substantially equivalent to K150893 (Hamilton Medical AG, 2016) after a 387-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- Apr 14, 2023
- Review
- 387 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K912723 (1991). 7 ancestors in all, the oldest K791045 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK912723 Posey CufflatorPosey Co. · 1991
- 3 generations backK081805 CuffalertSunmed · 2008
- 2 generations backK092733 PYTONArm Medical Devices, Inc. · 2010
- 1 generation backK150893 IntelliCuffHamilton Medical AG · 2016 · Recalled
- This deviceK220854 TrachCuff Cuff ControllerAw Technologies Aps · 2023
- Descendant · cites it directly · 0 of its ownK261499 TrachFlushAw Technologies Aps · 2026
Most influential descendants
Showing 1 of 1 · See all- K261499TrachFlushAw Technologies Aps · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912723 | Posey Cufflator | Posey Co. | 1991 | — |
| −3 | K081805 | Cuffalert | Sunmed | 2008 | — |
| −2 | K092733 | PYTON | Arm Medical Devices, Inc. | 2010 | — |
| −1 | K150893 | IntelliCuff | Hamilton Medical AG | 2016 | 2 |
| 0 (this device) | K220854 | TrachCuff Cuff Controller | Aw Technologies Aps | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 K261499 TrachFlushscore 13.0 · 5 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150893 | IntelliCuffSummary page 4…(3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K150893 IntelliCuff cuff Hamilton Medical AG, Bonaduz, controller Sw… | 2016 |
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 |
|---|---|---|---|
| K261499 | TrachFlush | 2026 | 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 32 years and passes through 5 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K261499 (Aw Technologies Aps, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K150893.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 TrachCuff Cuff Controller 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 TrachCuff Cuff Controller can be used with any mechanical ventilator.
The TrachCuff Cuff Controller 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/K220854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220854: TrachCuff Cuff Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220854
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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