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, Ltd. · NRY Catheter, Thrombus Retriever
Cleared on Jul 30, 2021 as substantially equivalent to K173452 (Neuravi, Ltd., 2018) and 2 other predicates after an 88-day review. Its family tree reaches back 10 generations to 2001. 2 later devices descend from it.
- Decided
- Jul 30, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K003410 (2001). 20 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 6 generations between
- 3 generations backK141491 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- 2 generations backK153071 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- 1 generation backK160641 Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
- This deviceK211338 EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK212908 EmboTrap II Revascularization Device, EMBOTRAP III Revascularization…Neuravi, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK251789 EMBOTRAP III Revascularization DeviceNeuravi Limited · 2025
Show all 10 generations
- Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 9 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 8 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 7 generations backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
- 6 generations backK090085 Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111…Concentric Medical, Inc. · 2009
- 5 generations backK113455 Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- 4 generations backK123378 Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- 3 generations backK141491 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- 2 generations backK153071 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- 1 generation backK160641 Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
- This deviceK211338 EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2021
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 |
|---|---|---|---|---|---|
| −10 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −9 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −8 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −7 | K063774 | Modification to Merci Retriever, Models X5 and X6 | Concentric Medical, Inc. | 2007 | — |
| −6 | K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 | Concentric Medical, Inc. | 2009 | — |
| −5 | K113455 | Solitaire FR Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| −4 | K123378 | Solitaire 2 Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| −3 | K141491 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
| −2 | K153071 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
| −1 | K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017 | — |
| 0 (this device) | K211338 | EMBOTRAP III Revascularization Device | Neuravi, Ltd. | 2021 | — |
| +1 | K212908 | EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device | Neuravi, Ltd. | 2021 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K173452 | EmboTrap ll Revascularization DeviceSummary page 4…atheter, Thrombus Retriever Classification Name: 21 CFR 870.1250 – Class II Product Code: NRY III. PREDICATE DEVICES EmboTrap® II Revascularization Device (K173452) EMBOTRAP™ III Revascularisation Device (5 x 22 mm and 5 x 37 mm models via K193063) Solitaire™ Platinum Revascularization Device… | 2018 |
| * | K193063 | EMBOTRAP III Revascularization DeviceSummary page 4…Product Code: NRY III. PREDICATE DEVICES EmboTrap® II Revascularization Device (K173452) EMBOTRAP™ III Revascularisation Device (5 x 22 mm and 5 x 37 mm models via K193063) Solitaire™ Platinum Revascularization Device (K160641) IV. DEVICE DESCRIPTION The EMBOTRAP™ III Revascularization Device is comp… | 2020 |
| * | K160641 | Solitaire Platinum Revascularization Device, 6x40 mmSummary page 4…® II Revascularization Device (K173452) EMBOTRAP™ III Revascularisation Device (5 x 22 mm and 5 x 37 mm models via K193063) Solitaire™ Platinum Revascularization Device (K160641) IV. DEVICE DESCRIPTION The EMBOTRAP™ III Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped s… | 2017 |
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 |
|---|---|---|---|
| K212908 | EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device | 2021 | 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K212908 (Neuravi, Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K173452.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211338 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211338: EMBOTRAP III Revascularization Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211338
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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