510(k) · Cleared

Cleared

Wholey Guide Wire System

K120863510(k) TraditionalCleared Apr 19, 201228-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

Covidien, LLC · DQX Wire, Guide, Catheter

Cleared on Apr 19, 2012 as substantially equivalent to K861765 (Advanced Cardiovascular Systems, Inc., 1986) after a 28-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided: Apr 19, 2012
Review: 28 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K861765 (1986). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK861765 Acs Wholey HI-Torque Guide WireAdvanced Cardiovascular Systems, Inc. · 1986
This deviceK120863 Wholey Guide Wire SystemCovidien, LLC · 2012
Descendant · cites it directly · 0 of its ownK193571 Go2Wire Guide WireMerit Medical System, Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all

K193571Go2Wire Guide WireMerit Medical System, Inc. · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K861765	Acs Wholey HI-Torque Guide Wire	Advanced Cardiovascular Systems, Inc.	1986	—
0 (this device)	K120863	Wholey Guide Wire System	Covidien, LLC	2012	—
+1	K193571	Go2Wire Guide Wire	Merit Medical System, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K120863, 1986–2020Source: 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

Get a 510(k) Report

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
*	K861765	Acs Wholey HI-Torque Guide Wire Summary page 1 …Code DQX Classification Panel Cardiovascular Predicate Devices Advanced Cardiovascular Systems Inc., WholeyTMl Hi-Torque® Guide Wire (K86 1765) Device Description The WholeyTM' Guide Wire System is a 0.035" guide wire available in lengths of 145…	Advanced Cardiovascular Systems, Inc.	1986	—

Also cleared against K861765: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K193571	Go2Wire Guide Wire	Merit Medical System, Inc.	2020	0

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?

Its one ancestor has no recall.
Of its descendants, K193571 (Merit Medical System, Inc., 2020) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K861765.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Wholey Guide Wire System is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guide wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120863 · printed Nov 5, 2026

Cite this page

510(k) Report. “K120863: Wholey Guide Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120863

Report an extraction error

Are you the manufacturer?

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