510(k) Report

FDA applicant

Catco Medical, Inc.

San Antonio, TX12 decisions1994–19951 recall

FDA records 12 decisions for Catco Medical, Inc. (San Antonio, TX) from 1994 to 1995: 12 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and LJS (Catheter, Intravascular, Therapeutic…). 1 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, general hospital panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Catco 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?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days5decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2decisions
  • BRWProtector, Dental1decision
  • JOLCatheter And Tip, Suction1decision
  • EZDCatheter, Straight1decision
  • FCNUrinary Drainage Collection Kit, For Indwelling Catheter1decision

Also: KNT (1).

Who builds on its devices?

Later devices cite its devices 4 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.

  • K945012Catco Nutritional CatheterCatco Medical, Inc. · 19952cite it
  • K944368Catco Silicone Umbilical Vessel CatheterCatco Medical, Inc. · 19951cites it
  • K944782Catco Urological CatheterCatco Medical, Inc. · 19941cites it

What has FDA decided for it lately?

  • K945728Catco Thoracic CatheterCatco Medical, Inc. · 1995
  • K944336Catco Umbilical Vessel CatheterCatco Medical, Inc. · 1995
  • K944368Catco Silicone Umbilical Vessel CatheterCatco Medical, Inc. · 1995
  • K944367Catco Polyurethane Umbilical Vessel CatheterCatco Medical, Inc. · 1995
  • K944410Catco Silicone Dual Lumen Umbilical Vessel CatheterCatco Medical, Inc. · 1995
  • K944685Cato First Picc-Dual LumenCatco Medical, Inc. · 1995
  • K944504Catco First PiccCatco Medical, Inc. · 1995
  • K945012Catco Nutritional CatheterCatco Medical, Inc. · 1995

All 12 as Catco Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K945499BD First PICC 3F 65 cm Single Lumen Procedure Kit.Apr 4, 2003