510(k) · Cleared

Recalled · 2003

Modified Concentric Retriever, Model 90037

K030476510(k) SpecialCleared Mar 11, 200326-day reviewClass II21 CFR 870.1250Recalls 2

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

Concentric Medical, Inc. · DQY Catheter, Percutaneous

Cleared on Mar 11, 2003 as substantially equivalent to K003410 (Concentric Medical, Inc., 2001) after a 26-day review. Its family tree reaches back 1 generation to 2001. 8 of the 166 devices in its family, counting itself, have a Class I recall. 164 later devices descend from it. It has been recalled 2 times.

Decided: Mar 11, 2003
Review: 26 days
Class: Class II
Product code: DQY
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K003410 (2001). 164 later devices descend from it, 4 citing it directly. 8 of the 166 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
This deviceK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003
Descendant · cites it directly · 159 of its ownK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
Descendant · 2 generations on · 120 of its ownK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
Descendant · 3 generations on · 118 of its ownK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
Descendant · 3 generations on · 116 of its ownK113163 Penumbra System MaxPenumbra, Inc. · 2011
Descendant · 3 generations on · 61 of its ownK133317 Penumbra System / Penumbra System MaxPenumbra, Inc. · 2014

Showing 5 of 164 descendants. See all descendants

Descendants cleared per year

2004high 20 (2025) · low 0 (2006)2026

Class I recalls in this family

K141516 Mindframe Capture LP Revascularization Device4 generations on · 2015
K190779 Trevo XP ProVue Retriever4 generations on · 2019
K162901 Penumbra 3D Revascularization Device6 generations on · 2017
K223530 Route 92 Medical Full Length 070 Reperfusion…6 generations on · 2023

Most influential descendants

Showing 5 of 164 · See all

K033736Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004 · cites it directly159descendants
K072718Penumbra SystemPenumbra, Inc. · 2007 · 2 generations on120descendants
K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054Penumbra, Inc. · 2010 · 3 generations on118descendants
K113163Penumbra System MaxPenumbra, Inc. · 2011 · 3 generations on116descendants
K133317Penumbra System / Penumbra System MaxPenumbra, Inc. · 2014 · 3 generations on61descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003410	Concentric Retriever, Model 90030	Concentric Medical, Inc.	2001	1
0 (this device)	K030476	Modified Concentric Retriever, Model 90037	Concentric Medical, Inc.	2003	—
+1	K033736	Merci Retriever, Models 90065, 90066	Concentric Medical, Inc.	2004	—
+2	K072718	Penumbra System	Penumbra, Inc.	2007	1
+3	K100769	Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032…	Penumbra, Inc.	2010	—
+3	K113163	Penumbra System Max	Penumbra, Inc.	2011	—
+3	K133317	Penumbra System / Penumbra System Max	Penumbra, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	1	0
2007	2	0
2009	1	0
2010	2	0
2011	2	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 K030476, 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 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
*	K003410	Concentric Retriever, Model 90030	Concentric Medical, Inc.	2001	1

Also cleared against K003410: 2 other devices →

What descends from it? (164)

See all 164

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

Number	Device	Applicant	Decided	Descendants
K033736	Merci Retriever, Models 90065, 90066	Concentric Medical, Inc.	2004	159
K040745	Modified Concentric Retriever, Model 90038	Concentric Medical, Inc.	2004	1
K093610	Modified Retriever (Modified, Line Extension), Models 90152, 90153	Concentric Medical, Inc.	2011	0
K040700	Concentric Retriever X5, Model 90035; Concentric Retriever X6, Model 90037	Concentric Medical, Inc.	2004	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 24, 2003	Not classified	Z-0085-04	Other	The device has the potential for tip breakage during use.
Sep 24, 2003	Not classified	Z-0086-04	Other	The device has the potential for tip breakage during use.

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 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K190779Trevo XP ProVue RetrieverStryker · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K162901Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · 6 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 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · 8 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
K191946Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · 9 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 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
K222786072 Aspiration SystemQ'Apel Medical, Inc. · 2023 · 10 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?

Its one ancestor has a recall.
Of its descendants, K033736 (Concentric Medical, Inc., 2004) has gone furthest, with 159 descendants of its own.
2 other devices also cite its predicate K003410.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030476 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030476: Modified Concentric Retriever, Model 90037.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030476

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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