510(k) · Cleared

Recalled · Class I · 2016

Roadrunner Uniglide Hydrophilic Wire Guide

K130766510(k) SpecialCleared Jul 17, 2013119-day reviewClass II21 CFR 870.1330Recalls 1 (1 Class I)

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

Cook, Inc. · DQX Wire, Guide, Catheter

Cleared on Jul 17, 2013 as substantially equivalent to K110009 (Cook, Inc., 2011) after a 119-day review. Its family tree reaches back 2 generations to 1992. 2 of the 4 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.

Decided: Jul 17, 2013
Review: 119 days
Class: Class II
Product code: DQX
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 2 generations to K920891 (1992). 3 ancestors in all. No later device cites it as a predicate yet. 2 of the 4 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK920891 Roadrunner (TM) Wire Guide, ModificationCook, Inc. · 1992
1 generation backK110009 Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2011 · Recalled (Class I)
This deviceK130766 Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2013

Class I recalls in this family

K110009 Roadrunner Uniglide Hydrophilic Wire Guidedirect predicate · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K920891	Roadrunner (TM) Wire Guide, Modification	Cook, Inc.	1992	—
−1	K110009	Roadrunner Uniglide Hydrophilic Wire Guide	Cook, Inc.	2011	Class I
0 (this device)	K130766	Roadrunner Uniglide Hydrophilic Wire Guide	Cook, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K130766, 1992–2013Source: 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.

2 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
*	K110009	Roadrunner Uniglide Hydrophilic Wire Guide Summary page 1 …Equivalence: The Roadrunner® UniGlide Tm Hydrophilic Wire Guideyose in this submission is substantially equivalent to the Roadrunner® tUniGlide THydrophilic Wire Guide (K 110009), which is currently marketed by Cook Incorporated. The proposed Roadrunner® UniGideTM Hydrophilic Wire Guide has indications for…	Cook, Inc.	2011	Class I

Also cleared against K110009: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 24, 2016	Class I	Z-2537-2016	Material/Component Contamination	Potential coating contamination with glass particles.

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.

K110009Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 18.1 years on median.
2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
1 other device also cites its predicate K110009.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?

For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130766 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130766: Roadrunner Uniglide Hydrophilic Wire Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130766

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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