510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

ERIC Retrieval Device

K211120510(k) TraditionalCleared Mar 31, 2022350-day reviewClass II21 CFR 870.1250Recalls 1

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

MicroVention, Inc. · NRY Catheter, Thrombus Retriever

Cleared on Mar 31, 2022 as substantially equivalent to K143077 (Concentric Medical, Inc., 2015) and 2 other predicates after a 350-day review. Its family tree reaches back 8 generations to 2001. It has been recalled once.

Decided
Mar 31, 2022
Review
350 days
Class
Class II
Product code
NRY
Recalls
1
Predicates
3

Its longest line of descent runs back 8 generations to K003410 (2001). 10 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 8 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 7 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
  3. 6 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
  4. 5 generations backK063774 Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc. · 2007
  5. 4 generations backK120961 Trevo RetrieverConcentric Medical, Inc. · 2012 · Recalled
  6. 3 generations backK122478 Modified Trevo RetrieverConcentric Medical, Inc. · 2012
  7. 2 generations backK132641 Modified Trevo Provue RetrieverConcentric Medical, Inc. · 2014 · Recalled
  8. 1 generation backK143077 Trevo XP ProVue Retriever (6X25mm)Concentric Medical, Inc. · 2015 · Recalled
  9. This deviceK211120 ERIC Retrieval DeviceMicroVention, Inc. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K003410Concentric Retriever, Model 90030Concentric Medical, Inc.20011
−7K030476Modified Concentric Retriever, Model 90037Concentric Medical, Inc.20032
−6K033736Merci Retriever, Models 90065, 90066Concentric Medical, Inc.2004—
−5K063774Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc.2007—
−4K120961Trevo RetrieverConcentric Medical, Inc.20121
−3K122478Modified Trevo RetrieverConcentric Medical, Inc.2012—
−2K132641Modified Trevo Provue RetrieverConcentric Medical, Inc.20144
−1K143077Trevo XP ProVue Retriever (6X25mm)Concentric Medical, Inc.20153
0 (this device)K211120ERIC Retrieval DeviceMicroVention, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
201510
FIG. 1 — Lineage of K211120, 2001–2022Source: 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K143077Trevo XP ProVue Retriever (6X25mm)
Summary page 4
…m Tel: (714) 247-8000 x 8162 Date: March 29, 2022 Predicate Device: Trevo XP ProVue Retriever (6x25 mm), K143077 Trevo XP ProVue Retriever (4x30mm), K150616 Modified Trevo ProVue Retri…
Concentric Medical, Inc.20153
*K150616Trevo XP ProVue Retriever (4x30mm)
Summary page 4
…March 29, 2022 Predicate Device: Trevo XP ProVue Retriever (6x25 mm), K143077 Trevo XP ProVue Retriever (4x30mm), K150616 Modified Trevo ProVue Retriever (3x20 mm and 4x20 mm), K132641 Reference Device: Solita…
Concentric Medical, Inc.2015—
*K132641Modified Trevo Provue Retriever
Summary page 4
…mm), K143077 Trevo XP ProVue Retriever (4x30mm), K150616 Modified Trevo ProVue Retriever (3x20 mm and 4x20 mm), K132641 Reference Device: Solitaire™ FR Revascularization Device (K113455) Device Description: The ERIC™ (Embolus…
Concentric Medical, Inc.20144
†K113455Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular2012—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 5, 2024Class IIZ-3157-2024Under Investigation by firmDue to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • 5 of the 10 ancestors have a recall of any class.

How does its category compare?

All NRY devices

NRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 ERIC Retrieval Device is indicated 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.

Cite this page

510(k) Report. “K211120: ERIC Retrieval Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211120

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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