510(k) · Cleared

Cleared

VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft) Model GW140SO

K051062510(k) TraditionalCleared Jul 15, 200580-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

Flowcardia, Inc. · DQX Wire, Guide, Catheter

Cleared on Jul 15, 2005 as substantially equivalent to K022762 (Jomed, Inc., 2002) and 3 other predicates after an 80-day review. Its family tree reaches back 6 generations to 1989.

Decided: Jul 15, 2005
Review: 80 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 4

Its longest line of descent runs back 6 generations to K890505 (1989). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
5 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
4 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
3 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
2 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
1 generation backK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
This deviceK051062 VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire…Flowcardia, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K890505	Usci Grey/Black Guide Wire	C.R. Bard, Inc.	1989	—
−5	K961271	Usci Commander Series Guide Wires	C.R. Bard, Inc.	1996	—
−4	K990639	Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat…	Guidant Corp.	1999	—
−3	K022762	Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000…	Jomed, Inc.	2002	—
−2	K031277	Jowire Asahi Ptca Catheter Guide Wires, Models…	Jomed, Inc.	2003	—
−1	K032615	Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300	Asahi Intecc Co., Ltd.	2003	—
0 (this device)	K051062	VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014…	Flowcardia, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	3	0

FIG. 1 — Lineage of K051062, 1989–2005Source: 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? (4)

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
*	K022762	Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002… Summary page 1 …I (21CFR 870.1330), CDRH Code DQX, Classification: Cardiovascular Panel Reason for 510(k): New Device Submission Substantially K022762 (original), K031277 (special), K(032615 equivalent to: (special) Asahi Wire, product code: DQX…	Jomed, Inc.	2002	—
*	K031277	Jowire Asahi Ptca Catheter Guide Wires, Models… Summary page 1 …CDRH Code DQX, Classification: Cardiovascular Panel Reason for 510(k): New Device Submission Substantially K022762 (original), K031277 (special), K(032615 equivalent to: (special) Asahi Wire, product code: DQX K(990639…	Jomed, Inc.	2003	—
*	K032615	Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 Summary page 1 …fication: Cardiovascular Panel Reason for 510(k): New Device Submission Substantially K022762 (original), K031277 (special), K(032615 equivalent to: (special) Asahi Wire, product code: DQX K(990639 CROSS IT 300XT, prod…	Asahi Intecc Co., Ltd.	2003	—
*	K990639	Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic… Summary page 1 …lly K022762 (original), K031277 (special), K(032615 equivalent to: (special) Asahi Wire, product code: DQX K(990639 CROSS IT 300XT, product code: DQX Contact Sterilizer: Nutek Corporation (Reg. No. 2950103)…	Guidant Corp.	1999	—

Also cleared against K022762: 22 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 16 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
None of the 9 ancestors has a recall.
22 other devices also cite its predicate K022762.

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 VP Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051062 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051062: VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft) Model GW140SO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051062

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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