510(k) · Cleared
ClearedVenner Tracheal Seal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venner Medical (Singapore) Pte, Ltd. · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Jul 28, 2011 as substantially equivalent to K885216 (Mallinckroot, Inc., 1989) and 1 other predicate after a 146-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jul 28, 2011
- Review
- 146 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K912723 (1991). 7 ancestors in all, the oldest K791045 (1979). No later device cites it as a predicate yet.
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) | K110631 | Venner Tracheal Seal Monitor | Venner Medical (Singapore) Pte, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 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 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 |
|---|---|---|---|
| * | K885216 | Attachable Lanz (Tentative)Summary page 2…000010 3 PREDICATE DEVICES The predicate devices are as follows: 1) the Lanz Pressure Valve cleared tinder premarket notification K8852 16; and, 2) the PYTON Cuff Pressure Regulator cleared under premnarket notification K092733. The predicate device… | 1989 |
| * | K092733 | PYTONSummary page 2…the Lanz Pressure Valve cleared tinder premarket notification K8852 16; and, 2) the PYTON Cuff Pressure Regulator cleared under premnarket notification K092733. The predicate devices are cuff pressure regulators, have been cleared by FDA and classified under 21 CFR § 868.5750, as Class 1… | 2010 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K885216.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Venner TM Tracheal Seal Monitor (TSM) is indicated for use to monitor maintain and regulate the pressure within the PneuX P. N'. TM Endotracheal or Tracheostomy Tube Cuff in adult patients who have been confined to hospital ICU units where intubation is expected to be more than 24 hours, but less than or equal to 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110631: Venner Tracheal Seal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110631
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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