510(k) · Cleared

Cleared

MS Amplatz Extra Stiff Guide Wire

K942382510(k) TraditionalCleared Aug 22, 199495-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

Meadox Surgimed, Inc. · DQX Wire, Guide, Catheter

Cleared on Aug 22, 1994 after a 95-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Aug 22, 1994
Review: 95 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK942382 MS Amplatz Extra Stiff Guide WireMeadox Surgimed, Inc. · 1994
Descendant · cites it directly · 0 of its ownK141218 Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire…Vadiswire Corporation · 2014
Descendant · cites it directly · 0 of its ownK980119 Acs HI-Torque Wholey Supra Core Guide WireGuidant Corp. · 1998

Most influential descendants

Showing 2 of 2 · See all

K141218Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire SystemVadiswire Corporation · 2014 · cites it directly0descendants
K980119Acs HI-Torque Wholey Supra Core Guide WireGuidant Corp. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K942382	MS Amplatz Extra Stiff Guide Wire	Meadox Surgimed, Inc.	1994	—
+1	K141218	Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire System	Vadiswire Corporation	2014	—
+1	K980119	Acs HI-Torque Wholey Supra Core Guide Wire	Guidant Corp.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2014	1	0

FIG. 1 — Lineage of K942382, 1994–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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
K141218	Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire System	Vadiswire Corporation	2014	0
K980119	Acs HI-Torque Wholey Supra Core Guide Wire	Guidant Corp.	1998	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?

Of its descendants, K141218 (Vadiswire Corporation, 2014) has gone furthest, with 0 descendants of its own.

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)	—

https://510kreport.com/device/K942382 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942382: MS Amplatz Extra Stiff Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942382

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026