510(k) · Cleared

Cleared

Cook Mreye Embolization Coils

K090624510(k) SpecialCleared Apr 2, 200924-day reviewClass II21 CFR 870.3300

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

Cook, Inc. · KRD Device, Vascular, For Promoting Embolization

Cleared on Apr 2, 2009 as substantially equivalent to K052834 (Cook, Inc., 2005) after a 24-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided: Apr 2, 2009
Review: 24 days
Class: Class II
Product code: KRD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K052834 (2005). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK052834 Mreye Embolization CoilCook, Inc. · 2005
This deviceK090624 Cook Mreye Embolization CoilsCook, Inc. · 2009
Descendant · cites it directly · 0 of its ownK150931 MReye Embolization CoilsCook Incorporated · 2015

Most influential descendants

Showing 1 of 1 · See all

K150931MReye Embolization CoilsCook Incorporated · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K052834	Mreye Embolization Coil	Cook, Inc.	2005	—
0 (this device)	K090624	Cook Mreye Embolization Coils	Cook, Inc.	2009	—
+1	K150931	MReye Embolization Coils	Cook Incorporated	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K090624, 2005–2015Source: 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 KRD? 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 KRD device

#1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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? (2)

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
*	K052834	Mreye Embolization Coil Summary page 1 …eral arterial and venous vessel embolization procedures. Predicate Devices: Cook MReye Embolization Coils (K052834) Cook Stainless Steel Embolization Coils (Pre-amendment) Device Description: The Cook M…	Cook, Inc.	2005	—
*	—	Cook Stainless Steel Embolization Coils Named without a submission number			—

Also cleared against K052834: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150931	MReye Embolization Coils	Cook Incorporated	2015	0

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?

Its one ancestor has no recall.
Of its descendants, K150931 (Cook Incorporated, 2015) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K052834.

How does its category compare?

All KRD devices

KRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KRD

9in 2025

2007high 11 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRD

60in 2025

2007high 178 (2019) · low 27 (2009)2026

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

Recalls per year · KRD

1in 2024

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRD

1,572in 2025

2007high 1,572 (2025) · low 14 (2008)2025

MAUDE reports naming product code KRD, 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	2	—	0	21
2008	5	84	0	14
2009	4	27	0	40
2010	3	150	1	61
2011	5	36	0	102
2012	8	30	0	137
2013	11	33	1	244
2014	7	134	0	159
2015	11	130	0	337
2016	4	164	0	437
2017	4	89	0	736
2018	4	62	0	1,066
2019	6	178	0	1,185
2020	4	137	0	1,167
2021	3	134	0	1,444
2022	8	175	0	1,498
2023	2	—	1	1,371
2024	6	70	1	1,535
2025	9	60	0	1,572
2026	7	70	1	—

What is it indicated for?

The Cook MReye Embolization Coil is used for peripheral arterial and venous vessel embolization procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090624 · printed Nov 5, 2026

Cite this page

510(k) Report. “K090624: Cook Mreye Embolization Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090624

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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