510(k) · Cleared

Cleared

Torque Device for a Guide Wire

K910969510(k) TraditionalCleared May 16, 199171-day reviewClass II21 CFR 870.1330

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

Terumo Corp. · DQX Wire, Guide, Catheter

Cleared on May 16, 1991 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.

Decided: May 16, 1991
Review: 71 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

32 later devices descend from it, 4 citing it directly.

This deviceK910969 Torque Device for a Guide WireTerumo Corp. · 1991
Descendant · cites it directly · 28 of its ownK032411 JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc. · 2003
Descendant · 2 generations on · 22 of its ownK060745 Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006
Descendant · 3 generations on · 21 of its ownK083313 Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009
Descendant · 4 generations on · 18 of its ownK102022 Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010
Descendant · 5 generations on · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2003high 6 (2012) · low 0 (2004)2026

Most influential descendants

Showing 5 of 32 · See all

K032411JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc. · 2003 · cites it directly28descendants
K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006 · 2 generations on22descendants
K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009 · 3 generations on21descendants
K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010 · 4 generations on18descendants
K111338Wildcat CatheterAvinger, Inc. · 2011 · 5 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K910969	Torque Device for a Guide Wire	Terumo Corp.	1991	—
+1	K032411	JS Vascular Guide Wire Vise/Torque Device	Js Vascular, Inc.	2003	—
+2	K060745	Asahi Tornus Support Catheter with Torque Device Accessory	Asahi Intecc Co., Ltd.	2006	—
+3	K083313	Wildcat 7F Guidewire Support Catheter	Avinger, Inc.	2009	—
+4	K102022	Wildcat 6F Guidewire Support Catheter Model W400L and W400S	Avinger, Inc.	2010	—
+5	K111338	Wildcat Catheter	Avinger, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0
2009	1	0
2010	3	0
2011	2	0
2012	6	0
2014	2	0
2015	2	0
2016	3	0
2017	2	0
2018	1	0
2020	2	0
2021	1	0
2022	3	0
2023	2	0

FIG. 1 — Lineage of K910969, 1991–2023Source: 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 DQX? 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 DQX device

#1 K213854 SavvyWirescore 15.7 · 10 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? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K032411	JS Vascular Guide Wire Vise/Torque Device	Js Vascular, Inc.	2003	28
K220934	RADIFOCUS Torque Device	Terumo Medical Products (Hangzhou) Co., Ltd.	2022	0
K143252	Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)	Needle Tech Products, Inc.	2015	0
K112674	Navis Torquer	Navis Medical,Inc	2012	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?

Of its descendants, K032411 (Js Vascular, Inc., 2003) has gone furthest, with 28 descendants of its own.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

https://510kreport.com/device/K910969 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910969: Torque Device for a Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910969

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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