510(k) · Cleared

Cleared

Modified Retriever (Modified, Line Extension), Models 90152, 90153

K093610510(k) TraditionalCleared Feb 17, 2011454-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 Feb 17, 2011 as substantially equivalent to K030476 (Concentric Medical, Inc., 2003) after a 454-day review. Its family tree reaches back 2 generations to 2001.

Decided: Feb 17, 2011
Review: 454 days
Class: Class II
Product code: NRY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K003410 (2001). No later device cites it as a predicate yet.

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 deviceK093610 Modified Retriever (Modified, Line Extension), Models 90152, 90153Concentric Medical, Inc. · 2011

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)	K093610	Modified Retriever (Modified, Line Extension), Models 90152, 90153	Concentric Medical, Inc.	2011	—

FIG. 1 — Lineage of K093610, 2001–2011Source: 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.

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

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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 …ed for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature. Predicate Device K030476 - Modified Concentric Retriever Model 90037 Device Description Like the predicate device, the Captix Retriever consists of a fle…	Concentric Medical, Inc.	2003	2

Also cleared against K030476: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 10 years and passes through 1 company; a new generation was cleared every 7.9 years on median.
2 of the 2 ancestors have a recall of any class.
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. 2011, this device’s year, is highlighted.

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 Captix Foreign Body Retriever is 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/K093610 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093610: Modified Retriever (Modified, Line Extension), Models 90152, 90153.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093610

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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