510(k) · Cleared

Recalled · Class II · 2022

Roadrunner PC Wire Guide, Olcott Torque Device

K182985510(k) TraditionalCleared Jul 22, 2019266-day reviewClass II21 CFR 870.1330Recalls 8

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

Cook Incorporated · DQX Wire, Guide, Catheter

Cleared on Jul 22, 2019 as substantially equivalent to K920891 (Cook, Inc., 1992) after a 266-day review. Its family tree reaches back 1 generation to 1992. It has been recalled 8 times.

Decided: Jul 22, 2019
Review: 266 days
Class: Class II
Product code: DQX
Recalls: 8
Predicates: 1

Its longest line of descent runs back 1 generation to K920891 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK920891 Roadrunner (TM) Wire Guide, ModificationCook, Inc. · 1992
This deviceK182985 Roadrunner PC Wire Guide, Olcott Torque DeviceCook Incorporated · 2019

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)	K182985	Roadrunner PC Wire Guide, Olcott Torque Device	Cook Incorporated	2019	—

FIG. 1 — Lineage of K182985, 1992–2019Source: 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
*	K920891	Roadrunner (TM) Wire Guide, Modification Summary page 4 …res, exclusive of the coronary arteries. Predicate Device: The predicate device, the Roadrunner Wire Guide, was cleared for commercial distribution under 510(k) number K920891, on December 21, 1992. Comparison to Predicate Device: It has been demonstrated that the subject device, Roadrunner® PC Wire Gu…	Cook, Inc.	1992	—
†	K171997	Mandril Wire Guide	Cook Incorporated	2018	3
†	K130766	Roadrunner Uniglide Hydrophilic Wire Guide	Cook, Inc.	2013	Class I

Also cleared against K920891: 2 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 16, 2022	Class II	Z-1839-2022	Under Investigation by firm	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Class II	Z-1840-2022	Under Investigation by firm	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Class II	Z-1838-2022	Under Investigation by firm	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Class II	Z-1841-2022	Under Investigation by firm	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Jul 19, 2022	Class II	Z-1708-2022	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-1706-2022	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-1709-2022	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-1707-2022	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.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K920891.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?

The Roadrunner® PC Wire Guide is used for catheter positioning and exchange in diagnostic and interventional procedures, exclusive of the coronary arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K182985 · printed Nov 4, 2026

Cite this page

510(k) Report. “K182985: Roadrunner PC Wire Guide, Olcott Torque Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182985

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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