510(k) Report

FDA applicant

Xentek Medical, Inc.

Athens, TX2 decisions2000–20006 recalls

FDA records 2 decisions for Xentek Medical, Inc. (Athens, TX) in 2000: 2 510(k) clearances. Most are in product codes DRE (Dilator, Vessel, For Percutaneous…) and DYB (Introducer, Catheter). 6 recalls are 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 Xentek Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Xentek Medical, Inc. since 2007.

Recalls per year

1in 2026

2010: 12018: 32025: 12026 (partial year): 1
2007high 3 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Xentek Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • DREDilator, Vessel, For Percutaneous Catheterization1decision
  • DYBIntroducer, Catheter1decision

Who builds on its devices?

Later devices cite its devices 9 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K000313Tearaway Introducer SheathXentek Medical, Inc. · 20006cite it
  • K000737Coaxial Dilator SetXentek Medical, Inc. · 20003cite it

What has FDA decided for it lately?

  • K000737Coaxial Dilator SetXentek Medical, Inc. · 20005 recalls
  • K000313Tearaway Introducer SheathXentek Medical, Inc. · 20001 recall

All 2 as Xentek Medical, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K021990Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP…Jun 26, 2026Class II
  • K000737B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41…Mar 27, 2025Class II
  • K000313Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901May 10, 2018Class II
  • K0007371) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10…May 2, 2018Class II
  • K000737TVS LPA, Catalog #: DIL-059-00May 2, 2018Class II
  • K000737Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204.…Feb 8, 2010