510(k) · Cleared
Recalled · Class II · 2023Puritan Bennett Cuff Pressure Manager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Jan 9, 2021 as substantially equivalent to K150893 (Hamilton Medical AG, 2016) after a 103-day review. Its family tree reaches back 4 generations to 1991. It has been recalled once.
- Decided
- Jan 9, 2021
- Review
- 103 days
- Class
- Class II
- Product code
- BSK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K912723 (1991). 7 ancestors in all, the oldest K791045 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK912723 Posey CufflatorPosey Co. · 1991
- 3 generations backK081805 CuffalertSunmed · 2008
- 2 generations backK092733 PYTONArm Medical Devices, Inc. · 2010
- 1 generation backK150893 IntelliCuffHamilton Medical AG · 2016 · Recalled
- This deviceK202874 Puritan Bennett Cuff Pressure ManagerCovidien, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912723 | Posey Cufflator | Posey Co. | 1991 | — |
| −3 | K081805 | Cuffalert | Sunmed | 2008 | — |
| −2 | K092733 | PYTON | Arm Medical Devices, Inc. | 2010 | — |
| −1 | K150893 | IntelliCuff | Hamilton Medical AG | 2016 | 2 |
| 0 (this device) | K202874 | Puritan Bennett Cuff Pressure Manager | Covidien, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 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? (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 |
|---|---|---|---|
| * | K150893 | IntelliCuffSummary page 5…510(k) K202874 Page 2 of 8 510(k) Number: K150893 (cleared January 29, 2016) Manufacturer Hamilton Medical AG Device Description The Puritan Bennett™ Cuff Pre… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2023 | Class II | Z-2651-2023 | Component design/selection | Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 3 other devices also cite its predicate K150893.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 CPM is intended to continuously measure and automatically maintain the cuff pressure of an endotracheal tube or tracheostomy tube that has been set by the user/clinician during mechanical ventilation. The CPM is intended for use with adult and pediatric patients during mechanical ventilation in the listed areas:
Intensive care unit (ICU)
Recovery room
Emergency medical care
Medical emergency vehicles when the patient is being transported
During transport within and outside of the hospital
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202874 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202874: Puritan Bennett Cuff Pressure Manager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202874
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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