510(k) · Cleared

Cleared

Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil

K961445510(k) TraditionalCleared Jul 9, 199684-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 Medical Corp. · DQX Wire, Guide, Catheter

Cleared on Jul 9, 1996 as substantially equivalent to K953533 (Terumo Medical Corp., 1995) after an 84-day review. Its family tree reaches back 1 generation to 1995. 5 of the 53 devices in its family, counting itself, have a Class I recall. 51 later devices descend from it.

Decided: Jul 9, 1996
Review: 84 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K953533 (1995). 51 later devices descend from it, 3 citing it directly. 5 of the 53 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
This deviceK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
Descendant · cites it directly · 31 of its ownK063695 Runthrough NSTerumo Medical Corp. · 2007 · Recalled
Descendant · cites it directly · 17 of its ownK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
Descendant · 2 generations on · 15 of its ownK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
Descendant · 3 generations on · 14 of its ownK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
Descendant · 2 generations on · 13 of its ownK103101 HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

1998high 5 (2011) · low 0 (1999)2026

Class I recalls in this family

K063525 Datascope Fiber Optic Pressure Sensor…4 generations on · 2007
K112372 Cardiosave Hybrid Intra-Aortic Balloon Pump5 generations on · 2011
K181122 CARDIOSAVE Intra-Aortic Balloon Pump6 generations on · 2018
K151254 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump6 generations on · 2015

Most influential descendants

Showing 5 of 51 · See all

K063695Runthrough NSTerumo Medical Corp. · 2007 · cites it directly31descendants
K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp. · 1998 · cites it directly17descendants
K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp. · 2000 · 2 generations on15descendants
K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Datascope Corp. · 2001 · 3 generations on14descendants
K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011 · 2 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953533	Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil	Terumo Medical Corp.	1995	—
0 (this device)	K961445	Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil	Terumo Medical Corp.	1996	—
+1	K063695	Runthrough NS	Terumo Medical Corp.	2007	1
+1	K980385	Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for…	Datascope Corp.	1998	—
+2	K994157	Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models…	Datascope Corp.	2000	—
+3	K013326	Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC…	Datascope Corp.	2001	—
+2	K103101	HI-Torque Balance Middleweight Elite	Abbott Vascular-Cardiac Therapies	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	1	0
2001	1	0
2002	2	0
2003	1	0
2004	1	0
2006	1	0
2007	2	1
2008	2	0
2009	3	0
2010	1	0
2011	5	1
2012	2	0
2013	1	0
2014	4	0
2015	4	1
2016	2	0
2017	4	1
2018	3	1
2019	3	0
2020	3	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K961445, 1995–2026Source: 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.

5 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 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? (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
*	K953533	Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil Summary page 1 …onary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA). Note: This is the same intended use as the Terumc Coronary Guide Wires cleared under 510(k) K953533. DESCRIPTION The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil have a core of titanium nickel alloy coated…	Terumo Medical Corp.	1995	—
†	K863138	Terumo Radifocus Guide Wire	Terumo Medical Corp.	1986	—
†	K913074	0.016 Guide Wire for Neurological Endoscope	Terumo Medical Corp.	1991	—
†	K925852	Terumo Coronary Guide Wire	Terumo Medical Corp.	1993	—

Also cleared against K953533: 1 other device →

What descends from it? (51)

See all 51

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

Number	Device	Applicant	Decided	Descendants
K063695	Runthrough NS	Terumo Medical Corp.	2007	31
K980385	Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…	Datascope Corp.	1998	17
K014195	Kayak Hydrophilic Guide Wires	Boston Scientific Corp	2002	0

Has anything in its family been recalled? (5 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.

K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 112 Class I recalls
K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K063695 (Terumo Medical Corp., 2007) has gone furthest, with 31 descendants of its own.
1 other device also cites its predicate K953533.

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)	—

What is it indicated for?

The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are used to facilitate the placement of ballon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

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/K961445 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961445: Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961445

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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