510(k) · Cleared

Recalled · Class I · 2022

Roadrunner Uniglide Hydrophilic Wire Guide

K110009510(k) SpecialCleared Feb 2, 201130-day reviewClass II21 CFR 870.1330Recalls 10 (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 Feb 2, 2011 as substantially equivalent to K091385 (Cook, Inc., 2009) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1992. 2 of the 5 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 10 times, including a Class I recall.

Decided: Feb 2, 2011
Review: 30 days
Class: Class II
Product code: DQX
Recalls: 10 (1 Class I)
Predicates: 2

Its longest line of descent runs back 1 generation to K920891 (1992). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK920891 Roadrunner (TM) Wire Guide, ModificationCook, Inc. · 1992
This deviceK110009 Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2011
Descendant · cites it directly · 0 of its ownK130766 Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2013 · Recalled (Class I)
Descendant · cites it directly · 0 of its ownK123707 Alight 16 Superselective Microwire GuideCook, Inc. · 2013

Class I recalls in this family

K130766 Roadrunner Uniglide Hydrophilic Wire Guidecites it directly · 2013

Most influential descendants

Showing 2 of 2 · See all

K130766Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2013 · cites it directly0descendants
K123707Alight 16 Superselective Microwire GuideCook, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K920891	Roadrunner (TM) Wire Guide, Modification	Cook, Inc.	1992	—
0 (this device)	K110009	Roadrunner Uniglide Hydrophilic Wire Guide	Cook, Inc.	2011	—
+1	K130766	Roadrunner Uniglide Hydrophilic Wire Guide	Cook, Inc.	2013	Class I
+1	K123707	Alight 16 Superselective Microwire Guide	Cook, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	2	1

FIG. 1 — Lineage of K110009, 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? (2)

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
*	K091385	Approach Hydro ST Wire Guide, Model HMW Summary page 1 …utaneous catheters into the peripheral vasculature. Predicate Devices: The Roadrunner Uni~lide Hydrophilic Wire Guide is identical to the Approach Hydro ST Wire Guide (K091385) in terms of intended use and similar to the Roadrunner Wire Guide (K920891) in terms of materials of construction and technologi…	Cook, Inc.	2009	1
*	K920891	Roadrunner (TM) Wire Guide, Modification Summary page 1 …Roadrunner Uni~lide Hydrophilic Wire Guide is identical to the Approach Hydro ST Wire Guide (K091385) in terms of intended use and similar to the Roadrunner Wire Guide (K920891) in terms of materials of construction and technological characteristics. Device Description: The Roadrunner Unilide Hydrophili…	Cook, Inc.	1992	—

Also cleared against K091385: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K130766	Roadrunner Uniglide Hydrophilic Wire Guide Class I	Cook, Inc.	2013	0
K123707	Alight 16 Superselective Microwire Guide	Cook, Inc.	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 19, 2022	Class II	Z-1710-2022	Under Investigation by firm	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Class II	Z-1717-2022	Under Investigation by firm	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Class II	Z-1715-2022	Under Investigation by firm	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Class II	Z-1713-2022	Under Investigation by firm	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Class II	Z-1712-2022	Under Investigation by firm	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Class II	Z-1711-2022	Under Investigation by firm	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Class II	Z-1718-2022	Under Investigation by firm	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Class II	Z-1714-2022	Under Investigation by firm	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Class II	Z-1716-2022	Under Investigation by firm	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jun 24, 2016	Class I	Z-2537-2016	Material/Component Contamination	Potential coating contamination with glass particles.

The 5 latest of 10 recalls; the web page lists all.

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.

K130766Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K130766 (Cook, Inc., 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K091385.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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/K110009 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110009: 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/K110009

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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