510(k) · Cleared

Cleared

Flipper Detachable Embolization Coil

K993455510(k) TraditionalCleared Jan 11, 200090-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 Jan 11, 2000 as substantially equivalent to K940189 (Cook, Inc., 1994) and 6 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1989. 41 later devices descend from it.

Decided: Jan 11, 2000
Review: 90 days
Class: Class II
Product code: KRD
Recalls: None
Predicates: 7

Its longest line of descent runs back 4 generations to K891688 (1989). 13 ancestors in all. 41 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
3 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
2 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
1 generation backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
This deviceK993455 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
Descendant · 3 generations on · 15 of its ownK071699 Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020…Aga Medical Corp. · 2007

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2003high 4 (2026) · low 0 (2004)2026

Most influential descendants

Showing 5 of 41 · See all

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
K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022Aga Medical Corp. · 2007 · 3 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K891688	Coil and Coil Delivery System	Target Therapeutics	1989	—
−3	K964367	Ces Vascular Occlusion System	Cordis Neurovascular, Inc.	1997	—
−2	K972881	Ces Vascular Occlusion System	Cordis Neurovascular, Inc.	1998	—
−1	K983483	Vascular Occlusion System	Cordis Neurovascular, Inc.	1999	—
0 (this device)	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	—
+3	K071699	Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022	Aga Medical Corp.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	0
1991	1	0
1994	2	0
1995	1	0
1996	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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	3	0
2014	3	0
2015	3	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 K993455, 1989–2026Source: 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.

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? (7)

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
*	K940189	Coil Positioner Set Summary page 2 …the percutaneous method of entry using a catheter or microcatheter introducer. The Embolization Coil Positioner Set was reviewed as substantially equivalent under D.C. K940189 and is indicated for arterial and venous embolization. The device is constructed of stainless steel and synthetic fiber with a co…	Cook, Inc.	1994	—
*	K901337	Hilal Embolization Microcoil (TM) Summary page 2 …in straight or curled shapes with an emboli gize range of 2 to 20 mm. A push-button release mechanism is the method of deployment. @ ) bstantially equivalent under D.C. K901337 ¥1dvenous malformations and other vascular lesions of the brain, spinal cord and spine. g ice is constructed of platinum and synt…	Cook, Inc.	1990	2
*	K983483	Vascular Occlusion System Summary page 2 …r. " Hilal Embolization Microcoils were review and are indicated for the embolization The Vascular Occlusion System was reviewed as substantially equivalent under D.C. K983483 and may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. It is intended for t…	Cordis Neurovascular, Inc.	1999	—
*	K951256	Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) Summary page 2 …eployment is achieved by a wire guide which pushes the coils out of the microcatheter. The Guglielmi Detachable Coil was reviewed as substantially equivalent under D.C. K951256, K960705 and K962503 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fist…	Target Therapeutics	1995	—
*	K960705	Guglielmi Detachable Coil Summary page 2 …is achieved by a wire guide which pushes the coils out of the microcatheter. The Guglielmi Detachable Coil was reviewed as substantially equivalent under D.C. K951256, K960705 and K962503 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae and…	Target Therapeutics	1996	—
*	K962503	Guglielmi Detachable Coil Summary page 2 …by a wire guide which pushes the coils out of the microcatheter. The Guglielmi Detachable Coil was reviewed as substantially equivalent under D.C. K951256, K960705 and K962503 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae and arterial ven…	Target Therapeutics	1996	—
*	K955293	Fibered Platinum Coil, .035 Type Summary page 2 …ange of 2 to 20 mm. The coils are deployed by electrolytic detachment from the wire guide. The Fibered Platinum coil was reviewed as substantially equivalent under D.C. K955293 and is indicated for arterial and venous embolization in the peripheral vasculature. The device is constructed of platinum and sy…	Target Therapeutics	1996	2

Also cleared against K940189: 2 other devices →

What descends from it? (41)

See all 41

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

Number	Device	Applicant	Decided	Descendants
K031810	Amplatzer Vascular Plug	Aga Medical Corp.	2003	38
K063619	Flipper Detachable Embolization Coils	Cook, Inc.	2006	1

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 11 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
2 of the 13 ancestors have a recall of any class.
Of its descendants, K031810 (Aga Medical Corp., 2003) has gone furthest, with 38 descendants of its own.
2 other devices also cite its predicate K940189.

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	—

What is it indicated for?

Used for arterial and venous embolization in the peripheral vasculature.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993455 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993455: Flipper Detachable Embolization Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993455

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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