510(k) · Cleared

Cleared

Modified Hydrophilic Coated Guidewire

K000011510(k) SpecialCleared Mar 1, 200058-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

Lake Region Mfg., Inc. · DQX Wire, Guide, Catheter

Cleared on Mar 1, 2000 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided: Mar 1, 2000
Review: 58 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

13 later devices descend from it, 3 citing it directly.

This deviceK000011 Modified Hydrophilic Coated GuidewireLake Region Mfg., Inc. · 2000
Descendant · cites it directly · 9 of its ownK092303 Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc. · 2009 · Recalled
Descendant · 2 generations on · 8 of its ownK120644 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2012 · Recalled
Descendant · 3 generations on · 6 of its ownK130588 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013
Descendant · 3 generations on · 5 of its ownK131710 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013
Descendant · 3 generations on · 5 of its ownK123609 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009high 4 (2013) · low 0 (2010)2026

Most influential descendants

Showing 5 of 13 · See all

K092303Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc. · 2009 · cites it directly9descendants
K120644Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2012 · 2 generations on8descendants
K130588Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013 · 3 generations on6descendants
K131710Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013 · 3 generations on5descendants
K123609Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000011	Modified Hydrophilic Coated Guidewire	Lake Region Mfg., Inc.	2000	—
+1	K092303	Merit Laureate Hydrophilic Guide Wire	Merit Medical Systems, Inc.	2009	6
+2	K120644	Merit Hydrophilic Guide Wire	Merit Medical Systems, Inc.	2012	2
+3	K130588	Merit Hydrophilic Guide Wire	Merit Medical Systems, Inc.	2013	—
+3	K131710	Merit Hydrophilic Guide Wire	Merit Medical Systems, Inc.	2013	—
+3	K123609	Merit Hydrophilic Guide Wire	Merit Medical Systems, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2012	1	0
2013	4	0
2014	2	0
2017	2	0
2020	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K000011, 2000–2026Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K092303	Merit Laureate Hydrophilic Guide Wire	Merit Medical Systems, Inc.	2009	9
K133155	Hydrophilic Coated Guidewire	Lake Region Medical	2014	1
K124052	Ostavi Hydrophilic Guidewire	Lake Region Medical	2013	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, K092303 (Merit Medical Systems, Inc., 2009) has gone furthest, with 9 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/K000011 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000011: Modified Hydrophilic Coated Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000011

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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