510(k) · Cleared

Cleared

Hydro-Select Guidewire

K954642510(k) TraditionalCleared Dec 17, 1996434-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

Microvena Corp. · DQX Wire, Guide, Catheter

Cleared on Dec 17, 1996 as substantially equivalent to K935232 (Kingston Technologies, Inc., 1994) and 2 other predicates after a 434-day review. Its family tree reaches back 1 generation to 1994.

Decided: Dec 17, 1996
Review: 434 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K935232 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK935232 Hydrotorque Guide WireKingston Technologies, Inc. · 1994
This deviceK954642 Hydro-Select GuidewireMicrovena Corp. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935232	Hydrotorque Guide Wire	Kingston Technologies, Inc.	1994	—
0 (this device)	K954642	Hydro-Select Guidewire	Microvena Corp.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0

FIG. 1 — Lineage of K954642, 1994–1996Source: 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
*	K935232	Hydrotorque Guide Wire Summary page 1 …me: The “HyTek” Hydrophilic Guidewire Common Name: Guidewire Classification Name: Wire Guide Catheter (per 21 CFR 870.1330) Predicate Devices: HydroTorque™ Guide Wire (K935232) ACS HI-TORQUE Guidewires The “NINER” .009” PTCA Guidewire (K952860) The M-PATH PTCA Guidewire (K946356) Device Description: Th…	Kingston Technologies, Inc.	1994	—
*	K952860	The Niner Nitinol Guidewire Cleared while this submission was under review Summary page 1 …fication Name: Wire Guide Catheter (per 21 CFR 870.1330) Predicate Devices: HydroTorque™ Guide Wire (K935232) ACS HI-TORQUE Guidewires The “NINER” .009” PTCA Guidewire (K952860) The M-PATH PTCA Guidewire (K946356) Device Description: The shaft of the HyTek Guidewire is constructed of Nitinol (nickel tit…	Microvena Corp.	1995	—
*	K946356	M-Path Nitinol Guidewire Summary page 1 …er 21 CFR 870.1330) Predicate Devices: HydroTorque™ Guide Wire (K935232) ACS HI-TORQUE Guidewires The “NINER” .009” PTCA Guidewire (K952860) The M-PATH PTCA Guidewire (K946356) Device Description: The shaft of the HyTek Guidewire is constructed of Nitinol (nickel titanium alloy). The Nitinol core is a c…	Microvena Corp.	1995	—
*	—	ACS HI-TORQUE Guidewires Named without a submission number			—

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?

None of the 3 ancestors has a recall.

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 HyTek Guidewire is intended for general intravascular use to aid in the selective placement of catheters in the coronary and peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.

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/K954642 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954642: Hydro-Select Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954642

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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