510(k) Report

FDA applicant

Kentron Health Care, Inc.

Hollywood, FL6 decisions1995–20030 recalls

FDA records 6 decisions for Kentron Health Care, Inc. (Hollywood, FL) from 1995 to 2003: 6 510(k) clearances. Most are in product codes FYC (Gown, Isolation, Surgical) and GDY (Gauze/Sponge, Internal, X-Ray Detectable). 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, general and plastic surgery panel, where it files most

How often FDA has decided Kentron Health Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kentron Health Care, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kentron Health Care, 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?

  • FYCGown, Isolation, Surgical2decisions
  • GDYGauze/Sponge, Internal, X-Ray Detectable1decision
  • HIBSpeculum, Vaginal, Nonmetal1decision
  • FLKThermometer, Clinical Mercury1decision
  • EFQGauze/Sponge, Internal1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K030693Kentex Disposable Vaginal SpeculumKentron Health Care, Inc. · 20031cites it

What has FDA decided for it lately?

  • K030693Kentex Disposable Vaginal SpeculumKentron Health Care, Inc. · 2003
  • K971917Kentron's Isolation GownKentron Health Care, Inc. · 1997
  • K972410Impervious Isolation GownKentron Health Care, Inc. · 1997
  • K953465KentempKentron Health Care, Inc. · 1995
  • K953914KentexKentron Health Care, Inc. · 1995
  • K953830KensorbKentron Health Care, Inc. · 1995

All 6 as Kentron Health Care, Inc. →