510(k) Report

FDA applicant

Buffalo Medical Specialties Mfg., Inc.

Clearwater, FL3 decisions1983–19900 recalls

FDA records 3 decisions for Buffalo Medical Specialties Mfg., Inc. (Clearwater, FL) from 1983 to 1990: 3 510(k) clearances. Most are in product codes JJQ (Colorimeter, Photometer, Spectrophotometer For…) and KNX (Collector, Urine, (And Accessories) For…). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Buffalo Medical Specialties Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Buffalo Medical Specialties Mfg., 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?

  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use1decision
  • KNXCollector, Urine, (And Accessories) For Indwelling Catheter1decision
  • DXQBlood Pressure Cuff1decision

What has FDA decided for it lately?

  • K902132Cuff, Blood PressureBuffalo Medical Specialties Mfg., Inc. · 1990
  • K852051External Male CatheterBuffalo Medical Specialties Mfg., Inc. · 1985
  • K830569Cynox I HemoglobinometerBuffalo Medical Specialties Mfg., Inc. · 1983

All 3 as Buffalo Medical Specialties Mfg., Inc. →

Other applicant names beginning “Buffalo”

FDA records each applicant name separately; these may or may not be the same firm.

Buffalo Filter Co., Inc. 24Buffalo Dental Mfg. Co., Inc. 11