De Novo · Granted
GrantedSentinel Cerebral Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Claret Medical, Inc. · PUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Granted on Jun 1, 2017 as a new device type through De Novo after a 254-day review. 2 later devices descend from it.
- Decided
- Jun 1, 2017
- Review
- 254 days
- Class
- Class II
- Product code
- PUM
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
- This deviceDEN160043 Sentinel Cerebral Protection SystemClaret Medical, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK192460 Sentinel Cerebral Protection SystemBoston Scientific Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK261715 Emboliner Embolic Protection System (EPC-03)Emboline, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160043 | Sentinel Cerebral Protection System | Claret Medical, Inc. | 2017 | — |
| +1 | K192460 | Sentinel Cerebral Protection System | Boston Scientific Corporation | 2020 | — |
| +2 | K261715 | Emboliner Embolic Protection System (EPC-03) | Emboline, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 PUM? 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 PUM device
- #1 K261715 Emboliner Embolic Protection System (EPC-03)score 12.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192460 | Sentinel Cerebral Protection System | 2020 | 1 |
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?
- Of its descendants, K192460 (Boston Scientific Corporation, 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PUM devicesPUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PUM
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PUM
Too few PUM 510(k)s in any year since 2007 to give a median.
Recalls per year · PUM
No recall names PUM since 2007.
Adverse event reports per year · PUM
49in 2025
MAUDE reports naming product code PUM, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 48 |
| 2020 | 1 | — | 0 | 73 |
| 2021 | 0 | — | 0 | 43 |
| 2022 | 0 | — | 0 | 40 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 45 |
| 2025 | 0 | — | 0 | 49 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Sentinel® Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 – 15 mm for the brachiocephalic and 6.5 – 10 mm in the left common carotid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN160043 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN160043: Sentinel Cerebral Protection System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN160043
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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