510(k) Report

510(k) · Cleared

Cleared

Modified Trevo Retriever

K122478510(k) TraditionalCleared Oct 31, 201278-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Concentric Medical, Inc. · NRY Catheter, Thrombus Retriever

Cleared on Oct 31, 2012 as substantially equivalent to K120961 (Concentric Medical, Inc., 2012) after a 78-day review. Its family tree reaches back 5 generations to 2001. 10 later devices descend from it.

Decided
Oct 31, 2012
Review
78 days
Class
Class II
Product code
NRY
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K003410 (2001). 6 ancestors in all. 10 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2018: 1 descendant cleared2014: 2 descendants cleared2015: 2 descendants cleared2022: 1 descendant cleared2021: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant clearedK003410 · Concentric Retriever, Model 90030 · Concentric Medical, Inc. · 2001 · recalledK030476 · Modified Concentric Retriever, Model 90037 · Concentric Medical, Inc. · 2003 · recalledK033736 · Merci Retriever, Models 90065, 90066 · Concentric Medical, Inc. · 2004K063774 · Modification to Merci Retriever, Models X5 and X6 · Concentric Medical, Inc. · 2007K120961 · Trevo Retriever · Concentric Medical, Inc. · 2012 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 1 descendant K120961 · Trevo Retriever · Concentric Medical, Inc. · 2012 · recalledK063774 · Modification to Merci Retriever, Models X5 and X6 · Concentric Medical, Inc. · 2007K033736 · Merci Retriever, Models 90065, 90066 · Concentric Medical, Inc. · 2004K030476 · Modified Concentric Retriever, Model 90037 · Concentric Medical, Inc. · 2003 · recalledK003410 · Concentric Retriever, Model 90030 · Concentric Medical, Inc. · 2001 · recalled−50
  1. Root · 5 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 4 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
  3. 3 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
  4. 2 generations backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
  5. 1 generation backK120961 Trevo RetrieverConcentric Medical, Inc. · 2012 · Recalled
  6. This deviceK122478 Modified Trevo RetrieverConcentric Medical, Inc. · 2012
  7. Descendant · cites it directly · 4 of its ownK173452 EmboTrap ll Revascularization DeviceNeuravi, Ltd. · 2018
  8. Descendant · 2 generations on · 3 of its ownK193063 EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2020
  9. Descendant · cites it directly · 3 of its ownK132641 Modified Trevo Provue RetrieverConcentric Medical, Inc. · 2014 · Recalled
  10. Descendant · 2 generations on · 2 of its ownK211338 EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2021
  11. Descendant · 2 generations on · 1 of its ownK212908 EmboTrap II Revascularization Device, EMBOTRAP III Revascularization…Neuravi, Ltd. · 2021

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2014: 22015: 22018: 12020: 12021: 22022: 12025: 1
2014high 2 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 10 · See all
  • K173452EmboTrap ll Revascularization DeviceNeuravi, Ltd. · 2018 · cites it directly4descendants
  • K193063EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2020 · 2 generations on3descendants
  • K132641Modified Trevo Provue RetrieverConcentric Medical, Inc. · 2014 · cites it directly3descendants
  • K211338EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2021 · 2 generations on2descendants
  • K212908EmboTrap II Revascularization Device, EMBOTRAP III Revascularization DeviceNeuravi, Ltd. · 2021 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K003410Concentric Retriever, Model 90030Concentric Medical, Inc.20011
−4K030476Modified Concentric Retriever, Model 90037Concentric Medical, Inc.20032
−3K033736Merci Retriever, Models 90065, 90066Concentric Medical, Inc.2004—
−2K063774Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc.2007—
−1K120961Trevo RetrieverConcentric Medical, Inc.20121
0 (this device)K122478Modified Trevo RetrieverConcentric Medical, Inc.2012—
+1K173452EmboTrap ll Revascularization DeviceNeuravi, Ltd.2018—
+2K193063EMBOTRAP III Revascularization DeviceNeuravi, Ltd.2020—
+1K132641Modified Trevo Provue RetrieverConcentric Medical, Inc.20144
+2K211338EMBOTRAP III Revascularization DeviceNeuravi, Ltd.2021—
+2K212908EmboTrap II Revascularization Device, EMBOTRAP III Revascularization DeviceNeuravi, Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201520
201810
202010
202120
202210
202510
FIG. 1 — Lineage of K122478, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232971 APRO 55 Catheter and Alembic Aspiration Tubingscore 18.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K120961Trevo RetrieverConcentric Medical, Inc.20121

Also cleared against K120961: 1 other device →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173452EmboTrap ll Revascularization DeviceNeuravi, Ltd.20184
K132641Modified Trevo Provue RetrieverConcentric Medical, Inc.20143
K133464Modified Trevo Provue RetrieverConcentric Medical, Inc.20140

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 11 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
  • 3 of the 6 ancestors have a recall of any class.
  • Of its descendants, K173452 (Neuravi, Ltd., 2018) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K120961.

How does its category compare?

All NRY devices

NRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · NRY

15in 2025

2007: 52008: 22009: 22010: 12011: 22012: 42014: 42015: 62016: 52017: 32018: 112019: 72020: 62021: 92022: 32023: 82024: 82025: 152026 (partial year): 14
2007high 15 (2025) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NRY

129in 2025

2007: 94 days median2012: 90 days median2014: 140 days median2015: 128 days median2016: 75 days median2017: 185 days median2018: 156 days median2019: 89 days median2020: 125 days median2021: 80 days median2022: 129 days median2023: 112 days median2024: 165 days median2025: 129 days median2026 (partial year): 147 days median
2007high 185 (2017) · low 75 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NRY

4in 2020

2010: 12013: 12017: 42020: 4, 4 Class I2026 (partial year): 2
2007high 4 (2017) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · NRY

565in 2025

2007: 132008: 182009: 572010: 2892011: 2632012: 3662013: 4052014: 4282015: 5982016: 4972017: 4322018: 4152019: 6502020: 7032021: 6882022: 5492023: 7112024: 6412025: 565
2007high 711 (2023) · low 13 (2007)2025

MAUDE reports naming product code NRY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007594013
20082—018
20092—057
20101—1289
20112—0263
20124900366
20130—1405
201441400428
201561280598
20165750497
201731854432
2018111560415
20197890650
202061254 (4)703
20219800688
202231290549
202381120711
202481650641
2025151290565
2026141472—

What is it indicated for?

The Modified Trevo Retriever 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.

Also cleared against K120961

1 other device cites the same predicate.

  • K190779Trevo XP ProVue RetrieverStryker · 20191 Class I recall

More from Concentric Medical, Inc.

45 FDA decisions under this applicant name. See the company

  • K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)Concentric Medical, Inc. · 20181 recall
  • DEN150049Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo…Concentric Medical, Inc. · 2016
  • K150616Trevo XP ProVue Retriever (4x30mm)Concentric Medical, Inc. · 2015
  • K143077Trevo XP ProVue Retriever (6X25mm)Concentric Medical, Inc. · 20153 recalls
  • K133177Modified HD Guide CatheterConcentric Medical, Inc. · 20143 recalls

Recent decisions in NRY

The NRY category page

  • K262021Toro 71 Aspiration Catheter; Toro Aspiration TubingToro Neurovascular, Inc. · 2026
  • K263266Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2026
  • K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing KitMaduro Medical, Inc. · 2026
  • K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd. · 2026
  • K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc. · 2026

https://510kreport.com/device/K122478 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122478: Modified Trevo Retriever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122478

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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