510(k) · Cleared
ClearedTRACOE smart Cuff Manager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tracoe Medical GmbH · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Sep 27, 2016 as substantially equivalent to K833327 (Respironics, Inc., 1983) and 1 other predicate after a 363-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Sep 27, 2016
- Review
- 363 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791045 (1979). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK791045 Model GV-10 Lanz Pressure-ValveExtracorporeal Medical Specialities, Inc. · 1979
- This deviceK152865 TRACOE smart Cuff ManagerTracoe Medical GmbH · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791045 | Model GV-10 Lanz Pressure-Valve | Extracorporeal Medical Specialities, Inc. | 1979 | — |
| 0 (this device) | K152865 | TRACOE smart Cuff Manager | Tracoe Medical GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 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 |
|---|---|---|---|
| * | K833327 | Respironics PR ValveSummary page 4…Device Product Code 510(k) # Smith Medical Inc. PressureEasy Cuff Pressure Controller BSK K833327 Covidien Model GV-10 Lanz Pressure Valve BTR K791045 Device Description: The T… | 1983 |
| * | K791045 | Model GV-10 Lanz Pressure-ValveSummary page 4…PressureEasy Cuff Pressure Controller BSK K833327 Covidien Model GV-10 Lanz Pressure Valve BTR K791045 Device Description: The TRACOE® smart Cuff Manager is an accessory device for high volume low pressure (HVLP) cuffed endotrache… | 1979 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K833327.
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 TRACOE® smart Cuff Manager is intended to maintain the HVLP (high volume low pressure) cuff pressure, of an endotracheal tube or tracheostomy tube, within the range of 20 to 30 cm H20 through passive control.
It is for single patient use, and indicated for mechanically ventilated or spontaneously breathing patients. It is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics and is suitable for inter- or intra-facility transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152865 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152865: TRACOE smart Cuff Manager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152865
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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