510(k) · Cleared

Cleared

Indy OTW Vascular Retriever

K160593510(k) TraditionalCleared Sep 2, 2016185-day reviewClass II21 CFR 870.5150

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

Cook Incorporated · MMX Device, Percutaneous Retrieval

Cleared on Sep 2, 2016 as substantially equivalent to K112185 (Cook, Inc., 2011) after a 185-day review. Its family tree reaches back 7 generations to 1990. 2 of the 17 devices in its family, counting itself, have a Class I recall.

Decided: Sep 2, 2016
Review: 185 days
Class: Class II
Product code: MMX
Recalls: None
Predicates: 1

Its longest line of descent runs back 7 generations to K901502 (1990). 16 ancestors in all. No later device cites it as a predicate yet. 2 of the 17 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 7 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
6 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
5 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
4 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
3 generations backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
2 generations backK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
1 generation backK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Recalled (Class I)
This deviceK160593 Indy OTW Vascular RetrieverCook Incorporated · 2016

Class I recalls in this family

K112185 Foursnare Vascular Retrieval Snaredirect predicate · 2011
K970466 Radius Ptca Guidewire5 generations back · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K901502	Amplatz Goose-Neck Snare	Microvena Corp.	1990	1
−6	K972511	Amplatz Goose Neck Snare Kit/ Catheter	Microvena Corp.	1998	1
−5	K021441	Radius Snare	Radius Medical Technologies, Inc.	2002	—
−4	K022201	Radius Micro Snare	Radius Medical Technologies, Inc.	2003	—
−3	K032426	Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set	Cook, Inc.	2003	—
−2	K073374	Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set	William Cook Europe Aps	2008	—
−1	K112185	Foursnare Vascular Retrieval Snare	Cook, Inc.	2011	Class I
0 (this device)	K160593	Indy OTW Vascular Retriever	Cook Incorporated	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1993	2	0
1997	1	1
1998	1	0
2000	1	0
2002	1	0
2007	1	0
2009	1	0

FIG. 1 — Lineage of K160593, 1990–2016Source: 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.

2 devices in this family have a Class I recall. 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 MMX device

#1 K242776 LimFlow V-Ceiverscore 10.9 · 8 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
*	K112185	Foursnare Vascular Retrieval Snare Summary page 4 …MMX III. PREDICATE DEVICE The device subject of this submission is considered substantially equivalent to the predicate device, the 4-Loop Vascular Retriever Snare (K112185). IV. DEVICE DESCRIPTION The Indy OTW™ Vascular Retriever consists of a 4-loop nitinol wire snare attached to an inner catheter…	Cook, Inc.	2011	Class I
†	K142829	Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…	Cook Incorporated	2015	Class I
†	K102484	Sequre Snare System	Lifetech Scientific (Shenzhen) Co., Ltd.	2010	—
†	K110009	Roadrunner Uniglide Hydrophilic Wire Guide	Cook, Inc.	2011	Class I
†	K110163	Approach Pro ST Wire Guide	Cook Incorporated	2011	—
†	K150970	Coda LP Balloon Catheter	Cook Incorporated	2015	—

Also cleared against K112185: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
4 of the 16 ancestors have a recall of any class; 2 have a Class I recall.
3 other devices also cite its predicate K112185.

How does its category compare?

All MMX devices

MMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · MMX

1in 2025

2007high 3 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMX

151in 2022

2007high 151 (2022)2026

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

Recalls per year · MMX

No recall names MMX since 2007.

Adverse event reports per year · MMX

49in 2025

2007high 49 (2025) · low 2 (2007)2025

MAUDE reports naming product code MMX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	2
2008	0	—	6
2009	2	—	6
2010	1	—	11
2011	1	—	15
2012	1	—	13
2013	0	—	10
2014	2	—	11
2015	2	—	5
2016	2	—	16
2017	2	—	29
2018	1	—	15
2019	1	—	17
2020	2	—	14
2021	1	—	22
2022	3	151	37
2023	2	—	40
2024	1	—	32
2025	1	—	49
2026	0	—	—

What is it indicated for?

The Indy OTW Vascular Retriever is intended to snare a foreign body and withdraw it to a peripheral vascular location.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K160593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160593: Indy OTW Vascular Retriever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160593

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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