510(k) · Cleared

Cleared

Merci Retriever, Models 90065, 90066

K033736510(k) TraditionalCleared Aug 11, 2004257-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 Aug 11, 2004 as substantially equivalent to K030476 (Concentric Medical, Inc., 2003) after a 257-day review. Its family tree reaches back 2 generations to 2001. 8 of the 162 devices in its family, counting itself, have a Class I recall. 159 later devices descend from it.

Decided: Aug 11, 2004
Review: 257 days
Class: Class II
Product code: NRY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K003410 (2001). 159 later devices descend from it, 2 citing it directly. 8 of the 162 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
1 generation backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
This deviceK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
Descendant · cites it directly · 120 of its ownK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
Descendant · 2 generations on · 118 of its ownK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
Descendant · 2 generations on · 116 of its ownK113163 Penumbra System MaxPenumbra, Inc. · 2011
Descendant · 2 generations on · 61 of its ownK133317 Penumbra System / Penumbra System MaxPenumbra, Inc. · 2014
Descendant · 2 generations on · 60 of its ownK142458 Penumbra System ACEPenumbra, Inc. · 2015

Showing 5 of 159 descendants. See all descendants

Descendants cleared per year

2007high 20 (2025) · low 0 (2008)2026

Class I recalls in this family

K141516 Mindframe Capture LP Revascularization Device3 generations on · 2015
K190779 Trevo XP ProVue Retriever3 generations on · 2019
K162901 Penumbra 3D Revascularization Device5 generations on · 2017
K223530 Route 92 Medical Full Length 070 Reperfusion…5 generations on · 2023

Most influential descendants

Showing 5 of 159 · See all

K072718Penumbra SystemPenumbra, Inc. · 2007 · cites it directly120descendants
K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054Penumbra, Inc. · 2010 · 2 generations on118descendants
K113163Penumbra System MaxPenumbra, Inc. · 2011 · 2 generations on116descendants
K133317Penumbra System / Penumbra System MaxPenumbra, Inc. · 2014 · 2 generations on61descendants
K142458Penumbra System ACEPenumbra, Inc. · 2015 · 2 generations on60descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003410	Concentric Retriever, Model 90030	Concentric Medical, Inc.	2001	1
−1	K030476	Modified Concentric Retriever, Model 90037	Concentric Medical, Inc.	2003	2
0 (this device)	K033736	Merci Retriever, Models 90065, 90066	Concentric Medical, Inc.	2004	—
+1	K072718	Penumbra System	Penumbra, Inc.	2007	1
+2	K100769	Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032…	Penumbra, Inc.	2010	—
+2	K113163	Penumbra System Max	Penumbra, Inc.	2011	—
+2	K133317	Penumbra System / Penumbra System Max	Penumbra, Inc.	2014	—
+2	K142458	Penumbra System ACE	Penumbra, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2009	1	0
2010	2	0
2011	1	0
2012	6	0
2014	4	0
2015	8	1
2016	8	0
2017	4	1
2018	16	0
2019	10	2
2020	14	2
2021	11	0
2022	7	0
2023	13	2
2024	12	0
2025	20	0
2026	20	0

FIG. 1 — Lineage of K033736, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

8 devices in this family have a Class I recall. 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K030476	Modified Concentric Retriever, Model 90037 Summary page 1 …odies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature. Predicate Devices Concentric Retriever K030476 Manufactured by Concentric Medical, Inc. Device Description The Merci Retriever consists of aNitinol tapered wire with a helical…	Concentric Medical, Inc.	2003	2

Also cleared against K030476: 3 other devices →

What descends from it? (159)

See all 159

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

Number	Device	Applicant	Decided	Descendants
K072718	Penumbra System	Penumbra, Inc.	2007	120
K063774	Modification to Merci Retriever, Models X5 and X6	Concentric Medical, Inc.	2007	37

Has anything in its family been recalled? (8 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K141516Mindframe Capture LP Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K190779Trevo XP ProVue RetrieverStryker · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K162901Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
K191946Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)Penumbra, Inc. · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
K222786072 Aspiration SystemQ'Apel Medical, Inc. · 2023 · 9 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

Nearest 5 of 8; all are on the web page.

What does this lineage say?

The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
2 of the 2 ancestors have a recall of any class.
Of its descendants, K072718 (Penumbra, Inc., 2007) has gone furthest, with 120 descendants of its own.
3 other devices also cite its predicate K030476.

How does its category compare?

All NRY devices

NRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NRY

15in 2025

2007high 15 (2025) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NRY

129in 2025

2007high 185 (2017) · low 75 (2016)2026

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

Recalls per year · NRY

4in 2020

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

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

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 Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033736 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033736: Merci Retriever, Models 90065, 90066.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033736

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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