510(k) Report

FDA applicant

Integrated Biomedical Technology, Inc.

Elkhart, IN3 decisions1996–20010 recalls

FDA records 3 decisions for Integrated Biomedical Technology, Inc. (Elkhart, IN) from 1996 to 2001: 3 510(k) clearances. Most are in product codes FKP (System, Dialysate Delivery, Single Patient) and MSY (Strip, Test, Reagent, Residuals For Dialysate…). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Integrated Biomedical Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Integrated Biomedical Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Integrated Biomedical Technology, 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?

  • FKPSystem, Dialysate Delivery, Single Patient2decisions
  • MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant1decision

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.

  • K964264High Range Peroxide Test StripIntegrated Biomedical Technology, Inc. · 19971cites it

What has FDA decided for it lately?

  • K002011Glutartest 1 Reagent StripIntegrated Biomedical Technology, Inc. · 2001
  • K964264High Range Peroxide Test StripIntegrated Biomedical Technology, Inc. · 1997
  • K953854Watercheck Reagent Strip for Chlorine & PeroxideIntegrated Biomedical Technology, Inc. · 1996

All 3 as Integrated Biomedical Technology, Inc. →