510(k) · Cleared
ClearedEmboliner Embolic Protection System (EPC-03)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emboline, Inc. · PUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Cleared on Sep 8, 2026 as substantially equivalent to K192460 (Boston Scientific Corporation, 2020) after a 109-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Sep 8, 2026
- Review
- 109 days
- Class
- Class II
- Product code
- PUM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160043 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K192460 Sentinel Cerebral Protection Systemscore 1.9 · 1 generation · 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 |
|---|---|---|---|
| * | K192460 | Sentinel Cerebral Protection SystemSummary page 5…1CFR 870.1251 Device Class: II Product Code: PUM Primary Predicate: Boston Scientific Corporation Sentinel Cerebral Protection System, K192460 Reference Device: Medtronic SpiderFX™ Embolic Protection Device, K111010 Date Prepared: May 15, 2026… | 2020 |
| † | K111010 | Spiderfx Embolic Protection Device | 2011 |
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 9 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 2 ancestors has a recall.
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. 2026, 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 Emboliner Embolic Protection System is indicated for use as an embolic protection device to capture and remove
embolic material during transcatheter aortic valve replacement (TAVR). Anatomical requirements for aortic diameters
and femoral access site to sinotubular junction (STJ) distance should meet the requirement as specified in the Instructions
for Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261715: Emboliner Embolic Protection System (EPC-03).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261715
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026