510(k) · Cleared
Recalled · Class II · 2026IntelliCuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Medical AG · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Jan 29, 2016 as substantially equivalent to K092733 (Arm Medical Devices, Inc., 2010) after a 302-day review. Its family tree reaches back 3 generations to 1991. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 29, 2016
- Review
- 302 days
- Class
- Class II
- Product code
- BSK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912723 (1991). 6 ancestors in all, the oldest K791045 (1979). 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK912723 Posey CufflatorPosey Co. · 1991
- 2 generations backK081805 CuffalertSunmed · 2008
- 1 generation backK092733 PYTONArm Medical Devices, Inc. · 2010
- This deviceK150893 IntelliCuffHamilton Medical AG · 2016
- Descendant · cites it directly · 1 of its ownK220854 TrachCuff Cuff ControllerAw Technologies Aps · 2023
- Descendant · 2 generations on · 0 of its ownK261499 TrachFlushAw Technologies Aps · 2026
- Descendant · cites it directly · 0 of its ownK243562 CuffGuardIdmed · 2025
- Descendant · cites it directly · 0 of its ownK221477 AG100sHospitech Respiration, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK202874 Puritan Bennett Cuff Pressure ManagerCovidien, LLC · 2021 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K220854TrachCuff Cuff ControllerAw Technologies Aps · 2023 · cites it directly1descendant
- K261499TrachFlushAw Technologies Aps · 2026 · 2 generations on0descendants
- K243562CuffGuardIdmed · 2025 · cites it directly0descendants
- K221477AG100sHospitech Respiration, Ltd. · 2022 · cites it directly0descendants
- K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912723 | Posey Cufflator | Posey Co. | 1991 | — |
| −2 | K081805 | Cuffalert | Sunmed | 2008 | — |
| −1 | K092733 | PYTON | Arm Medical Devices, Inc. | 2010 | — |
| 0 (this device) | K150893 | IntelliCuff | Hamilton Medical AG | 2016 | — |
| +1 | K220854 | TrachCuff Cuff Controller | Aw Technologies Aps | 2023 | — |
| +2 | K261499 | TrachFlush | Aw Technologies Aps | 2026 | — |
| +1 | K243562 | CuffGuard | Idmed | 2025 | — |
| +1 | K221477 | AG100s | Hospitech Respiration, Ltd. | 2022 | — |
| +1 | K202874 | Puritan Bennett Cuff Pressure Manager | Covidien, LLC | 2021 | 1 |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K092733 | PYTONSummary page 5…II Product Code: BSK III. Predicate Device(s) Primary Predicate Device ARM MEDICAL DEVICES, INC PYTON Cuff Regulator; K092733 This predicate has not been subject to a design-related recall Reference Device Hamilton Medical AG… | 2010 |
| † | K103803 | Hamilton-G5 | 2011 |
| † | K131774 | Hamilton-G5 | 2013 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2026 | Class II | Z-2625-2026 | Process design | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user. |
| Jun 20, 2017 | Class II | Z-0335-2018 | Component design/selection | Issue related to the performance of the motor in recalled product. During use, motor may cease to function. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K220854 (Aw Technologies Aps, 2023) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K092733.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 IntelliCuff 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 device can be used with any mechanical ventilator, as follows: When used with a non-Hamilton Medical ventilator, IntelliCuff adjusts the cuff pressure to values set on the device. When used with a Hamilton Medical ventilator, IntelliCuff adjusts the cuff…
Read the full statement (147 words)
The IntelliCuff 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 device can be used with any mechanical ventilator, as follows:
When used with a non-Hamilton Medical ventilator, IntelliCuff adjusts the cuff pressure to values set on the device.
When used with a Hamilton Medical ventilator, IntelliCuff adjusts the cuff pressure to values set either on the device or on the ventilator, depending on configuration.
The device is to be used during ventilation of adults, pediatrics, and neonates, who are intubated with ETT or TT, in the following areas:
In the intensive care ward or in the recovery room
In the operation room during intubation narcosis
For emergency medical care or primary care
During transport within and outside of the hospital
During transfer by rescue vehicles, ship, jet, or helicopter
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150893 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150893: IntelliCuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150893
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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