510(k) · Cleared

Cleared

Coil Positioner Set

K940189510(k) TraditionalCleared Nov 28, 1994319-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 Nov 28, 1994 after a 319-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it.

Decided: Nov 28, 1994
Review: 319 days
Class: Class II
Product code: KRD
Recalls: None
Predicates: 0

47 later devices descend from it, 3 citing it directly.

This deviceK940189 Coil Positioner SetCook, Inc. · 1994
Descendant · cites it directly · 41 of its ownK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
Descendant · cites it directly · 38 of its ownK031810 Amplatzer Vascular PlugAga Medical Corp. · 2003 · Recalled
Descendant · 2 generations on · 20 of its ownK043371 Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation · 2005
Descendant · 3 generations on · 17 of its ownK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
Descendant · 2 generations on · 16 of its ownK071125 Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008…Aga Medical Corp. · 2007

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

1999high 4 (2013) · low 0 (2001)2026

Most influential descendants

Showing 5 of 47 · See all

K993455Flipper Detachable Embolization CoilCook, Inc. · 2000 · cites it directly41descendants
K031810Amplatzer Vascular PlugAga Medical Corp. · 2003 · cites it directly38descendants
K043371Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation · 2005 · 2 generations on20descendants
K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008 · 3 generations on17descendants
K071125Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012…Aga Medical Corp. · 2007 · 2 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940189	Coil Positioner Set	Cook, Inc.	1994	—
+1	K993455	Flipper Detachable Embolization Coil	Cook, Inc.	2000	—
+1	K031810	Amplatzer Vascular Plug	Aga Medical Corp.	2003	1
+2	K043371	Biomerix Vascular Occlusion Device and Loader	Biomerix Corporation	2005	—
+3	K070961	Biomerix Surgical Mesh, Model: RCR-01	Biomerix Corporation	2008	—
+2	K071125	Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010…	Aga Medical Corp.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0
2003	1	0
2005	1	0
2006	1	0
2007	2	0
2008	2	0
2009	2	0
2010	1	0
2011	3	0
2012	2	0
2013	4	0
2014	3	0
2015	4	0
2016	2	0
2018	1	0
2019	1	0
2020	2	0
2021	1	0
2022	3	0
2023	1	0
2024	1	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K940189, 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K993455	Flipper Detachable Embolization Coil	Cook, Inc.	2000	41
K031810	Amplatzer Vascular Plug	Aga Medical Corp.	2003	38
K992121	Embolization Coil System	Cook, Inc.	1999	4

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, K993455 (Cook, Inc., 2000) has gone furthest, with 41 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/K940189 · printed Nov 4, 2026

Cite this page

510(k) Report. “K940189: Coil Positioner Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940189

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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