510(k) Report

FDA applicant

Klein-Baker Medical, Inc.

San Antonio, TX5 decisions1996–19971 recall

FDA records 5 decisions for Klein-Baker Medical, Inc. (San Antonio, TX) from 1996 to 1997: 5 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and MIA (Needle, Spinal, Short Term). 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 Klein-Baker Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Klein-Baker Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • MIANeedle, Spinal, Short Term1decision
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1decision
  • KDJSet, Administration, For Peritoneal Dialysis, Disposable1decision
  • FOSCatheter, Umbilical Artery1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K970997Neo-Care Lumber Puncture KitKlein-Baker Medical, Inc. · 19971cites it
  • K970434Neo-PiccKlein-Baker Medical, Inc. · 19971cites it

What has FDA decided for it lately?

  • K972731Neo-Care Peritoneal Dialysis Administration SetKlein-Baker Medical, Inc. · 1997
  • K970997Neo-Care Lumber Puncture KitKlein-Baker Medical, Inc. · 1997
  • K970434Neo-PiccKlein-Baker Medical, Inc. · 19971 recall
  • K963972Neo-Care Dual Lumen Umbilical CatheterKlein-Baker Medical, Inc. · 1996
  • K963867Neo-Care Catheterization TrayKlein-Baker Medical, Inc. · 1996

All 5 as Klein-Baker Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K970434NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The…Nov 24, 2004