510(k) · Cleared

Cleared

Acs HI-Torque Wholey Supra Core Guide Wire

K980119510(k) TraditionalCleared Mar 20, 199866-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

Guidant Corp. · DQX Wire, Guide, Catheter

Cleared on Mar 20, 1998 as substantially equivalent to K852123 (Advanced Cardiovascular Systems, Inc., 1985) and 3 other predicates after a 66-day review. Its family tree reaches back 1 generation to 1985.

Decided: Mar 20, 1998
Review: 66 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K852123 (1985). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK852123 Wholey HI-Torque Guide WiresAdvanced Cardiovascular Systems, Inc. · 1985
This deviceK980119 Acs HI-Torque Wholey Supra Core Guide WireGuidant Corp. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K852123	Wholey HI-Torque Guide Wires	Advanced Cardiovascular Systems, Inc.	1985	—
0 (this device)	K980119	Acs HI-Torque Wholey Supra Core Guide Wire	Guidant Corp.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1993	1	0
1994	1	0

FIG. 1 — Lineage of K980119, 1985–1998Source: 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? (4)

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
*	K852123	Wholey HI-Torque Guide Wires Summary page 1 …PRA CORE™ Guide Wire Device Common Name: Guide Wire Device Classification Name: Catheter Guide Wire (74DQX) Predicate Devices: ~ Wholey Hi-Torque Standard® Guide Wire (852123, approved June 19, 1985 and K861765 approved May 30, 1986), Hi-Torque S’Port-T™ Guide Wire (K915554, approved February 9, 1993) a…	Advanced Cardiovascular Systems, Inc.	1985	—
*	K861765	Acs Wholey HI-Torque Guide Wire Summary page 1 …Name: Guide Wire Device Classification Name: Catheter Guide Wire (74DQX) Predicate Devices: ~ Wholey Hi-Torque Standard® Guide Wire (852123, approved June 19, 1985 and K861765 approved May 30, 1986), Hi-Torque S’Port-T™ Guide Wire (K915554, approved February 9, 1993) and Medi-tech Amplatz Super Stiff Gui…	Advanced Cardiovascular Systems, Inc.	1986	—
*	K915554	HI-Torque Sport-T (TM) Guide Wire Summary page 1 …e (74DQX) Predicate Devices: ~ Wholey Hi-Torque Standard® Guide Wire (852123, approved June 19, 1985 and K861765 approved May 30, 1986), Hi-Torque S’Port-T™ Guide Wire (K915554, approved February 9, 1993) and Medi-tech Amplatz Super Stiff Guide Wire (K942382, approved August 22, 1994) Device Description:…	Peripheral Systems Group	1993	—
*	K942382	MS Amplatz Extra Stiff Guide Wire Summary page 1 …roved June 19, 1985 and K861765 approved May 30, 1986), Hi-Torque S’Port-T™ Guide Wire (K915554, approved February 9, 1993) and Medi-tech Amplatz Super Stiff Guide Wire (K942382, approved August 22, 1994) Device Description: The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is a steerable guide wire with a…	Meadox Surgimed, Inc.	1994	—

Also cleared against K852123: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 4 ancestors has a recall.
1 other device also cites its predicate K852123.

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?

The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980119 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980119: Acs HI-Torque Wholey Supra Core Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980119

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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