510(k) · Cleared
ClearedCuffalert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunmed · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Nov 14, 2008 as substantially equivalent to K912723 (Posey Co., 1991) and 1 other predicate after a 141-day review. Its family tree reaches back 1 generation to 1991. 8 of the 36 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it.
- Decided
- Nov 14, 2008
- Review
- 141 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912723 (1991). 2 ancestors in all. 33 later devices descend from it, 3 citing it directly. 8 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK912723 Posey CufflatorPosey Co. · 1991
- This deviceK081805 CuffalertSunmed · 2008
- 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 · cites it directly · 7 of its ownK102704 Easy CuffJoan Spiegel, MD · 2011
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 33 · 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
- K102704Easy CuffJoan Spiegel, MD · 2011 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912723 | Posey Cufflator | Posey Co. | 1991 | — |
| 0 (this device) | K081805 | Cuffalert | Sunmed | 2008 | — |
| +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 |
| +1 | K102704 | Easy Cuff | Joan Spiegel, MD | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 1 |
| 2012 | 2 | 1 |
| 2013 | 3 | 2 |
| 2015 | 2 | 0 |
| 2016 | 3 | 1 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 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), 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.
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? (2)
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 |
|---|---|---|---|
| * | K912723 | Posey CufflatorSummary page 1…Cuff, tracheal tube, inflatable (accessory) BSK - 868.5730 Predicate Devices: Posey Cufflator - K912723 Rusch Endotest - K951046 Device Description: The CuffAlertTM is a simple in-line pres… | 1991 |
| * | K951046 | Rusch Endotest Cuff Pressure MonitorSummary page 1…BSK - 868.5730 Predicate Devices: Posey Cufflator - K912723 Rusch Endotest - K951046 Device Description: The CuffAlertTM is a simple in-line pressure monitor which contains a calibrated diaphragm which distends wi… | 1995 |
What descends from it? (33)
See all 333 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
To measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
The CuffAlertTM is not intended to replacement clinical judgment.
Patients who are intubated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081805 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081805: Cuffalert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081805
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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