510(k) · Cleared

Cleared

Guidewires, Various Types

K920884510(k) TraditionalCleared Aug 19, 1992230-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

Acme-Monaco Corp. · DQX Wire, Guide, Catheter

Cleared on Aug 19, 1992 after a 230-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 28 later devices descend from it.

Decided: Aug 19, 1992
Review: 230 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

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

This deviceK920884 Guidewires, Various TypesAcme-Monaco Corp. · 1992
Descendant · cites it directly · 25 of its ownK982559 GuidewireGalt Medical Corp. · 1999 · Recalled
Descendant · 2 generations on · 13 of its ownK042370 Torayguide GuidewireToray Industries (America), Inc. · 2004
Descendant · 3 generations on · 11 of its ownK132623 Medtronic Confida Brecker Curve GuidewireMedtronic · 2013
Descendant · 4 generations on · 9 of its ownK150465 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015
Descendant · 5 generations on · 8 of its ownK181001 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

1999high 3 (2015) · low 0 (2000)2026

Most influential descendants

Showing 5 of 28 · See all

K982559GuidewireGalt Medical Corp. · 1999 · cites it directly25descendants
K042370Torayguide GuidewireToray Industries (America), Inc. · 2004 · 2 generations on13descendants
K132623Medtronic Confida Brecker Curve GuidewireMedtronic · 2013 · 3 generations on11descendants
K150465Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015 · 4 generations on9descendants
K181001Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018 · 5 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K920884	Guidewires, Various Types	Acme-Monaco Corp.	1992	—
+1	K982559	Guidewire	Galt Medical Corp.	1999	1
+2	K042370	Torayguide Guidewire	Toray Industries (America), Inc.	2004	—
+3	K132623	Medtronic Confida Brecker Curve Guidewire	Medtronic	2013	—
+4	K150465	Medtronic Confida Brecker Guidewire	Medtronic Core Valve, LLC	2015	—
+5	K181001	Medtronic Confida Brecker Guidewire	Medtronic Core Valve, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2003	2	0
2004	1	0
2010	1	0
2011	1	0
2013	1	0
2015	3	0
2016	1	0
2017	2	0
2018	3	0
2019	1	0
2020	1	0
2022	2	0
2023	2	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K920884, 1992–2026Source: 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (28)

See all 28

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K982559	Guidewire	Galt Medical Corp.	1999	25
K101199	Guide Wire for Edi Catheter, 8FR,125CM,5 Each,Guide Wire for Edi Catheter, 8FR,125CM,5…	Maquet Critical Care AB	2010	1

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, K982559 (Galt Medical Corp., 1999) has gone furthest, with 25 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/K920884 · printed Nov 4, 2026

Cite this page

510(k) Report. “K920884: Guidewires, Various Types.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920884

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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