510(k) · Cleared
ClearedCuff-Mate 2 Endotracheal Cuff Inflator & Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diemolding Corp. · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Jul 18, 1990 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 of the 29 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Jul 18, 1990
- Review
- 68 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 1 citing it directly. 8 of the 29 devices in this family, counting this one, have a Class I recall.
- This deviceK902114 Cuff-Mate 2 Endotracheal Cuff Inflator & MonitorDiemolding Corp. · 1990
- Descendant · cites it directly · 27 of its ownK092733 PYTONArm Medical Devices, Inc. · 2010
- Descendant · 2 generations on · 14 of its ownK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 10 of its ownK131774 Hamilton-G5Hamilton Medical AG · 2013 · Recalled (Class I)
- Descendant · 3 generations on · 8 of its ownK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK150893 IntelliCuffHamilton Medical AG · 2016 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K092733PYTONArm Medical Devices, Inc. · 2010 · cites it directly27descendants
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 generations on14descendants
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 3 generations on10descendants
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on8descendants
- K150893IntelliCuffHamilton Medical AG · 2016 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902114 | Cuff-Mate 2 Endotracheal Cuff Inflator & Monitor | Diemolding Corp. | 1990 | — |
| +1 | K092733 | PYTON | Arm Medical Devices, Inc. | 2010 | — |
| +2 | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | Class I |
| +3 | K131774 | Hamilton-G5 | Hamilton Medical AG | 2013 | Class I |
| +3 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
| +2 | K150893 | IntelliCuff | Hamilton Medical AG | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 2 | 1 |
| 2013 | 3 | 2 |
| 2015 | 1 | 0 |
| 2016 | 3 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2020 | 3 | 1 |
| 2021 | 2 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
8 devices in this family have a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (28)
See all 281 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092733 | PYTON | 2010 | 27 |
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- Of its descendants, K092733 (Arm Medical Devices, Inc., 2010) has gone furthest, with 27 descendants of its own.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K902114 · printed Nov 5, 2026
Cite this page
510(k) Report. “K902114: Cuff-Mate 2 Endotracheal Cuff Inflator & Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K902114
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026