510(k) · Cleared

Cleared

Arterial Embolization Device (KRD)

K940982510(k) TraditionalCleared Oct 14, 1994227-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 Oct 14, 1994 after a 227-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 70 later devices descend from it.

Decided: Oct 14, 1994
Review: 227 days
Class: Class II
Product code: KRD
Recalls: None
Predicates: 0

70 later devices descend from it, 1 citing it directly.

This deviceK940982 Arterial Embolization Device (KRD)Cook, Inc. · 1994
Descendant · cites it directly · 69 of its ownK993418 Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilBoston Scientific, Target · 2000 · Recalled
Descendant · 2 generations on · 67 of its ownK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
Descendant · 3 generations on · 66 of its ownK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
Descendant · 3 generations on · 65 of its ownK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
Descendant · 3 generations on · 36 of its ownK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007

Showing 5 of 70 descendants. See all descendants

Descendants cleared per year

2000high 11 (2013) · low 0 (2001)2026

Most influential descendants

Showing 5 of 70 · See all

K993418Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilBoston Scientific, Target · 2000 · cites it directly69descendants
K033836Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · 2 generations on67descendants
K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004 · 3 generations on66descendants
K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · 3 generations on65descendants
K070656Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007 · 3 generations on36descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940982	Arterial Embolization Device (KRD)	Cook, Inc.	1994	—
+1	K993418	Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil	Boston Scientific, Target	2000	1
+2	K033836	Hydrocoil Embolic System (Hes)	MicroVention, Inc.	2003	—
+3	K041551	Modification to: Hydrocoil Embolic System (Hes)	MicroVention, Inc.	2004	—
+3	K050954	Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)	MicroVention, Inc.	2005	16
+3	K070656	Hydrocoil Embolic System (Hes)	MicroVention, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0
2003	1	0
2004	1	0
2005	1	0
2007	1	0
2008	3	0
2009	7	0
2010	4	0
2011	5	0
2012	5	0
2013	11	0
2014	4	0
2015	4	0
2016	3	0
2017	2	0
2018	2	0
2019	1	0
2020	3	0
2021	1	0
2022	5	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K940982, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (70)

See all 70

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

Number	Device	Applicant	Decided	Descendants
K993418	Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil	Boston Scientific, Target	2000	69

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?

Of its descendants, K993418 (Boston Scientific, Target, 2000) has gone furthest, with 69 descendants of its own.

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.

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	—

https://510kreport.com/device/K940982 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940982: Arterial Embolization Device (KRD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940982

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026