510(k) · Cleared
ClearedEMBOTRAP III Revascularization Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuravi Limited · NRY Catheter, Thrombus Retriever
Cleared on Sep 25, 2025 as substantially equivalent to K212908 (Neuravi, Ltd., 2021) after a 106-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Sep 25, 2025
- Review
- 106 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K003410 (2001). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 8 generations between
- 3 generations backK160641 Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
- 2 generations backK211338 EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2021
- 1 generation backK212908 EmboTrap II Revascularization Device, EMBOTRAP III Revascularization…Neuravi, Ltd. · 2021
- This deviceK251789 EMBOTRAP III Revascularization DeviceNeuravi Limited · 2025
Show all 12 generations
- Root · 12 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 11 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 10 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 9 generations backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
- 8 generations backK090085 Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111…Concentric Medical, Inc. · 2009
- 7 generations backK113455 Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- 6 generations backK123378 Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- 5 generations backK141491 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- 4 generations backK153071 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- 3 generations backK160641 Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
- 2 generations backK211338 EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2021
- 1 generation backK212908 EmboTrap II Revascularization Device, EMBOTRAP III Revascularization…Neuravi, Ltd. · 2021
- This deviceK251789 EMBOTRAP III Revascularization DeviceNeuravi Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −11 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −10 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −9 | K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | 2007 | — |
| −8 | K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 | Concentric Medical, Inc. | 2009 | — |
| −7 | K113455 | Solitaire FR Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| −6 | K123378 | Solitaire 2 Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| −5 | K141491 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
| −4 | K153071 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
| −3 | K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017 | — |
| −2 | K211338 | EMBOTRAP III Revascularization Device | Neuravi, Ltd. | 2021 | — |
| −1 | K212908 | EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device | Neuravi, Ltd. | 2021 | — |
| 0 (this device) | K251789 | EMBOTRAP III Revascularization Device | Neuravi Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 NRY? 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 NRY device
- #1 K232971 APRO 55 Catheter and Alembic Aspiration Tubingscore 18.6 · 10 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 |
|---|---|---|---|
| * | K212908 | EmboTrap II Revascularization Device, EMBOTRAP III Revascularization DeviceSummary page 5…er Classification Name: 21 CFR 870.1250 – Class II Product Code: NRY III. PREDICATE AND REFERENCE DEVICES Predicate: EMBOTRAP™III Revascularization Device (K212908, October 13, 2021) Reference: EMBOTRAP™III Revascularization Device (K193063, July 14, 2020) IV. DEVICE DESCRIPTION The EMBOTRAP™… | 2021 |
| † | K193063 | EMBOTRAP III Revascularization Device | 2020 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 22 ancestors have a recall of any class.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NRY
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NRY
129in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NRY
4in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · NRY
565in 2025
MAUDE reports naming product code NRY, 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 | 5 | 94 | 0 | 13 |
| 2008 | 2 | — | 0 | 18 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 289 |
| 2011 | 2 | — | 0 | 263 |
| 2012 | 4 | 90 | 0 | 366 |
| 2013 | 0 | — | 1 | 405 |
| 2014 | 4 | 140 | 0 | 428 |
| 2015 | 6 | 128 | 0 | 598 |
| 2016 | 5 | 75 | 0 | 497 |
| 2017 | 3 | 185 | 4 | 432 |
| 2018 | 11 | 156 | 0 | 415 |
| 2019 | 7 | 89 | 0 | 650 |
| 2020 | 6 | 125 | 4 (4) | 703 |
| 2021 | 9 | 80 | 0 | 688 |
| 2022 | 3 | 129 | 0 | 549 |
| 2023 | 8 | 112 | 0 | 711 |
| 2024 | 8 | 165 | 0 | 641 |
| 2025 | 15 | 129 | 0 | 565 |
| 2026 | 14 | 147 | 2 | — |
What is it indicated for?
The EMBOTRAP III Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251789 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251789: EMBOTRAP III Revascularization Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251789
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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