510(k) · Cleared

Recalled · Class II · 2026

Galt Medical Guidewire

K021990510(k) SpecialCleared Jul 18, 200230-day reviewClass II21 CFR 870.1330Recalls 1

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

Galt Medical Corp. · DQX Wire, Guide, Catheter

Cleared on Jul 18, 2002 as substantially equivalent to K982559 (Galt Medical Corp., 1999) after a 30-day review. Its family tree reaches back 2 generations to 1992. 8 later devices descend from it. It has been recalled once.

Decided: Jul 18, 2002
Review: 30 days
Class: Class II
Product code: DQX
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K920884 (1992). 8 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK920884 Guidewires, Various TypesAcme-Monaco Corp. · 1992
1 generation backK982559 GuidewireGalt Medical Corp. · 1999 · Recalled
This deviceK021990 Galt Medical GuidewireGalt Medical Corp. · 2002
Descendant · cites it directly · 5 of its ownK151234 R350 guidewireVascular Solutions, Inc. · 2015
Descendant · 2 generations on · 4 of its ownK161702 Endura guidewireVascular Solutions, Inc. · 2016
Descendant · 3 generations on · 3 of its ownK163444 Spectre guidewireVascular Solutions, Inc. · 2017
Descendant · 4 generations on · 1 of its ownK173532 Raider GuidewireVascular Solutions, Inc. · 2017
Descendant · cites it directly · 1 of its ownK031916 Galt Medical GuidewireGalt Medical Corp. · 2003 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all

K151234R350 guidewireVascular Solutions, Inc. · 2015 · cites it directly5descendants
K161702Endura guidewireVascular Solutions, Inc. · 2016 · 2 generations on4descendants
K163444Spectre guidewireVascular Solutions, Inc. · 2017 · 3 generations on3descendants
K173532Raider GuidewireVascular Solutions, Inc. · 2017 · 4 generations on1descendant
K031916Galt Medical GuidewireGalt Medical Corp. · 2003 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K920884	Guidewires, Various Types	Acme-Monaco Corp.	1992	—
−1	K982559	Guidewire	Galt Medical Corp.	1999	1
0 (this device)	K021990	Galt Medical Guidewire	Galt Medical Corp.	2002	—
+1	K151234	R350 guidewire	Vascular Solutions, Inc.	2015	—
+2	K161702	Endura guidewire	Vascular Solutions, Inc.	2016	—
+3	K163444	Spectre guidewire	Vascular Solutions, Inc.	2017	—
+4	K173532	Raider Guidewire	Vascular Solutions, Inc.	2017	—
+1	K031916	Galt Medical Guidewire	Galt Medical Corp.	2003	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2015	1	0
2016	1	0
2017	2	0
2018	2	0

FIG. 1 — Lineage of K021990, 1992–2018Source: 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
*	K982559	Guidewire Summary page 1 …ide, Catheter Classification Code: DQX (3) Substantial Equivalency: Galt Medical Corp. guidewires (Mandrel Type) are substantially equivalent to guidewires i?om K982559. (4) Device Description: The materials of construction stainless steel, nitinol, platinum are consistent with guidewires pre…	Galt Medical Corp.	1999	1

Also cleared against K982559: 4 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K151234	R350 guidewire	Vascular Solutions, Inc.	2015	5
K031916	Galt Medical Guidewire	Galt Medical Corp.	2003	1
K033542	Easy Pass Hydrophilic Coated Vascular Guidewire	Galt Medical Corp.	2003	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 26, 2026	Class II	Z-2917-2026	Under Investigation by firm	Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
1 of the 2 ancestors has a recall of any class.
Of its descendants, K151234 (Vascular Solutions, Inc., 2015) has gone furthest, with 5 descendants of its own.
4 other devices also cite its predicate K982559.

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?

These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021990 · printed Nov 3, 2026

Cite this page

510(k) Report. “K021990: Galt Medical Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021990

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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