510(k) · Cleared

Cleared

TXM Hydrophilic Guidewire

K170915510(k) TraditionalCleared Nov 21, 2017238-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

Texasmedical Technologies, Inc. · DQX Wire, Guide, Catheter

Cleared on Nov 21, 2017 as substantially equivalent to K133155 (Lake Region Medical, 2014) after a 238-day review. Its family tree reaches back 2 generations to 2000.

Decided: Nov 21, 2017
Review: 238 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K000011 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK000011 Modified Hydrophilic Coated GuidewireLake Region Mfg., Inc. · 2000
1 generation backK133155 Hydrophilic Coated GuidewireLake Region Medical · 2014
This deviceK170915 TXM Hydrophilic GuidewireTexasmedical Technologies, Inc. · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000011	Modified Hydrophilic Coated Guidewire	Lake Region Mfg., Inc.	2000	—
−1	K133155	Hydrophilic Coated Guidewire	Lake Region Medical	2014	—
0 (this device)	K170915	TXM Hydrophilic Guidewire	Texasmedical Technologies, Inc.	2017	—

FIG. 1 — Lineage of K170915, 2000–2017Source: 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K133155	Hydrophilic Coated Guidewire Summary page 4 …uide, Catheter Regulation Number: 21 CFR 870.1330 Product Code: DQX Device Class: II 510(k) Number K133155 5.4 – Device Description The TXM Hydrophilic Guidewire is a hydrophilic coated device which is constructed with a nit…	Lake Region Medical	2014	—

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 17 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
None of the 2 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. 2017, 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?

To facilitate the placement of devices during diagnostic or interventional procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K170915 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170915: TXM Hydrophilic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170915

Report an extraction error

Are you the manufacturer?

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