510(k) · Cleared

Cleared

Merit Heparin-Coated Inqwire Diagnostic Guidewire

K140608510(k) SpecialCleared Sep 12, 2014186-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

Merit Medical Systems, Inc. · DQX Wire, Guide, Catheter

Cleared on Sep 12, 2014 as substantially equivalent to K822586 (Universal Medical Instrument Corp., 1982) and 1 other predicate after a 186-day review. Its family tree reaches back 2 generations to 2000.

Decided: Sep 12, 2014
Review: 186 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K002289 (2000). 3 ancestors in all, the oldest K822586 (1982). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002289 Inqwire Diagnostic Guide WireMerit Medical Systems, Inc. · 2000
1 generation backK133230 Inqwire Diagnostic Guide WireMerit Medical Systems, Inc. · 2013
This deviceK140608 Merit Heparin-Coated Inqwire Diagnostic GuidewireMerit Medical Systems, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002289	Inqwire Diagnostic Guide Wire	Merit Medical Systems, Inc.	2000	—
−1	K133230	Inqwire Diagnostic Guide Wire	Merit Medical Systems, Inc.	2013	—
0 (this device)	K140608	Merit Heparin-Coated Inqwire Diagnostic Guidewire	Merit Medical Systems, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0

FIG. 1 — Lineage of K140608, 2000–2014Source: 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? (2)

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
*	K822586	Teflon Coated Guide Wires & Catheter Summary page 4 …e#1: Trade Name: InQwire® Classification Name: 21 CFR 870.1330 Catheter guide wire Premarket Notification: K822586 Manufacturer: Merit Medical Systems, Inc. Predicate Device Premarket Notificatio…	Universal Medical Instrument Corp.	1982	—
*	K133230	Inqwire Diagnostic Guide Wire Summary page 4 …e#2: Trade Name: InQwire® Classification Name: 21 CFR 870.1330 Catheter guide wire Premarket Notification: K133230 Manufacturer: Merit Medical Systems, Inc. Class II 21 CFR 870.1330…	Merit Medical Systems, Inc.	2013	—

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 14 years and passes through 1 company; a new generation was cleared every 13.2 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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?

Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140608 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140608: Merit Heparin-Coated Inqwire Diagnostic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140608

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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