510(k) · Cleared

Cleared

Radifocus Glidewire

K152740510(k) TraditionalCleared Nov 16, 201554-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

Ashitaka Factory of Terumo Corp. · DQX Wire, Guide, Catheter

Cleared on Nov 16, 2015 as substantially equivalent to K863138 (Terumo Medical Corp., 1986) after a 54-day review. Its family tree reaches back 1 generation to 1986. 8 later devices descend from it.

Decided: Nov 16, 2015
Review: 54 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K863138 (1986). 8 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK863138 Terumo Radifocus Guide WireTerumo Medical Corp. · 1986
This deviceK152740 Radifocus GlidewireAshitaka Factory of Terumo Corp. · 2015
Descendant · cites it directly · 3 of its ownK201081 AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V. · 2020
Descendant · 2 generations on · 2 of its ownK223918 AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V. · 2023
Descendant · 3 generations on · 1 of its ownK233853 LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. · 2024
Descendant · cites it directly · 0 of its ownK253146 Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026
Descendant · cites it directly · 0 of its ownK261281 CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2020high 3 (2024) · low 0 (2021)2026

Most influential descendants

Showing 5 of 8 · See all

K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V. · 2020 · cites it directly3descendants
K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V. · 2023 · 2 generations on2descendants
K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. · 2024 · 3 generations on1descendant
K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026 · cites it directly0descendants
K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863138	Terumo Radifocus Guide Wire	Terumo Medical Corp.	1986	—
0 (this device)	K152740	Radifocus Glidewire	Ashitaka Factory of Terumo Corp.	2015	—
+1	K201081	AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter	Philips Medical System Nederland B.V.	2020	—
+2	K223918	AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub	Philips Medical Systems Nederland B.V.	2023	—
+3	K233853	LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub	Philips Medical Systems Nederland B.V.	2024	—
+1	K253146	Hyperdrive 35 Guidewire	Rapid-Medical, Ltd.	2026	—
+1	K261281	CROSSLEAD Standard 035 and CROSSLEAD Stiff 035	Filmecc Co., Ltd.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0
2023	1	0
2024	3	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K152740, 1986–2026Source: 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 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? (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
*	K863138	Terumo Radifocus Guide Wire Summary page 5 …DQX Classification: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is:  K863138 – Terumo Radifocus Guide Wire, manufactured by Ashitaka Factory of Terumo Corporation  Additional reference…	Terumo Medical Corp.	1986	—
†	K151471	Radifocus Glidewire Endoscopic Wire	Terumo Medical Corporation	2015	—

Also cleared against K863138: 11 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K201081	AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter	Philips Medical System Nederland B.V.	2020	3
K253146	Hyperdrive 35 Guidewire	Rapid-Medical, Ltd.	2026	0
K261281	CROSSLEAD Standard 035 and CROSSLEAD Stiff 035	Filmecc Co., Ltd.	2026	0
K240818	R2P Radifocus Glidewire Advantage	Terumo Corporation	2024	0
K232662	BNLE Hydrophilic Jacketed Peripheral Guidewire	Biomerics Nle	2024	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?

Its one ancestor has no recall.
Of its descendants, K201081 (Philips Medical System Nederland B.V., 2020) has gone furthest, with 3 descendants of its own.
11 other devices also cite its predicate K863138.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

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 Glidewire is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152740 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152740: Radifocus Glidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152740

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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