510(k) · Cleared

Cleared

Scimed Quest Floppy and Moderate Support Guide Wires

K980360510(k) TraditionalCleared Apr 29, 199890-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

Scimed Life Systems, Inc. · DQX Wire, Guide, Catheter

Cleared on Apr 29, 1998 as substantially equivalent to K943192 (Scimed Life Systems, Inc., 1994) and 12 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1994.

Decided: Apr 29, 1998
Review: 90 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 13

Its longest line of descent runs back 3 generations to K941895 (1994). 22 ancestors in all, the oldest K931514 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
2 generations backK962572 Scimed Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1996 · Recalled
1 generation backK965023 Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1997
This deviceK980360 Scimed Quest Floppy and Moderate Support Guide WiresScimed Life Systems, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K941895	Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating	Scimed Life Systems, Inc.	1994	—
−2	K962572	Scimed Choice PT Vision Ptca Guide Wire	Scimed Life Systems, Inc.	1996	3
−1	K965023	Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire	Scimed Life Systems, Inc.	1997	—
0 (this device)	K980360	Scimed Quest Floppy and Moderate Support Guide Wires	Scimed Life Systems, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	4	0
1995	8	0
1996	3	0
1997	2	0
1998	1	0

FIG. 1 — Lineage of K980360, 1994–1998Source: 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? (13)

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
*	K943192	Scimed Choice (TM) Ptca Guide Wire Summary page 1 …ter Guide Wire PTCA Guide Wire Proprietary Name SCIMED® Quest™ Floppy and Moderate Support Guide Wires Predicate Device 510(k) Reference No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K…	Scimed Life Systems, Inc.	1994	—
*	K945129	Scimed Chioce Plus Ptca Guide Wire Summary page 1 …Wire PTCA Guide Wire Proprietary Name SCIMED® Quest™ Floppy and Moderate Support Guide Wires Predicate Device 510(k) Reference No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K…	Scimed Life Systems, Inc.	1995	—
*	K950113	Scimed (R) Chice (TM) Exchange Ptca Guide Wire Summary page 1 …CA Guide Wire Proprietary Name SCIMED® Quest™ Floppy and Moderate Support Guide Wires Predicate Device 510(k) Reference No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K…	Scimed Life Systems, Inc.	1995	—
*	K950141	Scimed (R) Choice (TM) Ptca Guide Wire Summary page 1 …Wire Proprietary Name SCIMED® Quest™ Floppy and Moderate Support Guide Wires Predicate Device 510(k) Reference No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K960563 P…	Scimed Life Systems, Inc.	1995	—
*	K961015	Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire Summary page 1 …prietary Name SCIMED® Quest™ Floppy and Moderate Support Guide Wires Predicate Device 510(k) Reference No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K960563 Page 4 ==…	Scimed Life Systems, Inc.	1996	—
*	K964551	Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice… Summary page 1 …Name SCIMED® Quest™ Floppy and Moderate Support Guide Wires Predicate Device 510(k) Reference No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K960563 Page 4 === Page 2…	Scimed Life Systems, Inc.	1997	—
*	K965023	Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire Summary page 1 …ED® Quest™ Floppy and Moderate Support Guide Wires Predicate Device 510(k) Reference No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K960563 Page 4 510(k…	Scimed Life Systems, Inc.	1997	—
*	K970244	Scimed Choice Family of Ptca Guide Wires Summary page 1 …™ Floppy and Moderate Support Guide Wires Predicate Device 510(k) Reference No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K960563 Page 4 510(k) Notific…	Scimed Life Systems, Inc.	1997	—
*	K973945	Luge Guide Wire Summary page 1 …port Guide Wires Predicate Device 510(k) Reference No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K960563 Page 4 510(k) Notification SCIMED® Quest™ Gui…	Scimed Life Systems, Inc.	1998	—
*	K942333	Scimed EN Tre' Iii Ptca Guide Wire Summary page 1 …k) Reference No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K960563 Page 4 510(k) Notification SCIMED® Quest™ Guide Wires Summary of Safety and Effecti…	Scimed Life Systems, Inc.	1994	—
*	K946240	Scimed (R) Sceptor (TM) Ptca Guide Wire Summary page 1 …nce No. ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K960563 Page 4 510(k) Notification SCIMED® Quest™ Guide Wires Summary of Safety and Effectiveness, c…	Scimed Life Systems, Inc.	1995	—
*	K950534	Scimed Sceptor Ptca Guide Wire Summary page 1 …ChoICE Guide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K960563 Page 4 510(k) Notification SCIMED® Quest™ Guide Wires Summary of Safety and Effectiveness, continued…	Scimed Life Systems, Inc.	1995	—
*	K960563	Scimed Sceptor & Sceptor Exchange Ptca Guide Wires Summary page 1 …ide Wire Family K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244 Luge Guide Wire K973945 Sceptor and Sceptor Exchange K942333, K946240, K950534, K960563 Page 4 510(k) Notification SCIMED® Quest™ Guide Wires Summary of Safety and Effectiveness, continued Section 4…	Scimed Life Systems, Inc.	1996	—

Also cleared against K943192: 4 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
2 of the 22 ancestors have a recall of any class.
4 other devices also cite its predicate K943192.

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 SCIMED Quest Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Quest Guide Wires are 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/K980360 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980360: Scimed Quest Floppy and Moderate Support Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980360

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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