510(k) · Cleared
ClearedSentinel Cerebral Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · PUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Cleared on Feb 19, 2020 as substantially equivalent to DEN160043 (Claret Medical, Inc., 2017) after a 163-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.
- Decided
- Feb 19, 2020
- Review
- 163 days
- Class
- Class II
- Product code
- PUM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160043 (2017). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN160043 Sentinel Cerebral Protection SystemClaret Medical, Inc. · 2017
- This deviceK192460 Sentinel Cerebral Protection SystemBoston Scientific Corporation · 2020
- Descendant · cites it directly · 0 of its ownK261715 Emboliner Embolic Protection System (EPC-03)Emboline, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261715Emboliner Embolic Protection System (EPC-03)Emboline, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160043 | Sentinel Cerebral Protection System | Claret Medical, Inc. | 2017 | — |
| 0 (this device) | K192460 | Sentinel Cerebral Protection System | Boston Scientific Corporation | 2020 | — |
| +1 | K261715 | Emboliner Embolic Protection System (EPC-03) | Emboline, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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
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 |
|---|---|---|---|
| * | DEN160043 | Sentinel Cerebral Protection SystemSummary page 4…intracardiac procedures Product Code PUM Classification Class II, 21 CFR Part 870.1251 Predicate Device Sentinel Cerebral Protection DEN160043 June 1, 2017 System Device Description The Sentinel™ Cerebral Protection System (Sentinel CPS) is a 6 F… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261715 | Emboliner Embolic Protection System (EPC-03) | 2026 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K261715 (Emboline, Inc., 2026) has gone furthest, with 0 descendants 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. 2020, 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/K192460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192460: Sentinel Cerebral Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192460
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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