510(k) Report

FDA applicant

Texasmedical Technologies, Inc.

El Paso, TX7 decisions2015–20170 recalls

FDA records 7 decisions for Texasmedical Technologies, Inc. (El Paso, TX) from 2015 to 2017: 7 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 238 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Texasmedical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2015: 22016: 32017: 2
2015high 3 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Texasmedical Technologies, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Texasmedical Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQOCatheter, Intravascular, Diagnostic2decisions
  • DQYCatheter, Percutaneous2decisions
  • DYBIntroducer, Catheter1decision
  • LITCatheter, Angioplasty, Peripheral, Transluminal1decision
  • DQXWire, Guide, Catheter1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 238 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142817IntraNovo 25 MicrocatheterTexasmedical Technologies, Inc. · 20151cites it

What has FDA decided for it lately?

  • K170914TXM Support CatheterTexasmedical Technologies, Inc. · 2017
  • K170915TXM Hydrophilic GuidewireTexasmedical Technologies, Inc. · 2017
  • K153771TXM Guiding SheathTexasmedical Technologies, Inc. · 2016
  • K153703Guiding CatheterTexasmedical Technologies, Inc. · 2016
  • K153125IntraNovo MicrocatheterTexasmedical Technologies, Inc. · 2016
  • K142954PTA 14 Balloon Dilatation Catheter OTWTexasmedical Technologies, Inc. · 2015
  • K142817IntraNovo 25 MicrocatheterTexasmedical Technologies, Inc. · 2015

All 7 as Texasmedical Technologies, Inc. →