510(k) Report

FDA applicant

Tecnadyne Scientific, Inc.

Vero Beach, FL5 decisions1990–19940 recalls

FDA records 5 decisions for Tecnadyne Scientific, Inc. (Vero Beach, FL) from 1990 to 1994: 5 510(k) clearances. Most are in product codes KZD (Infusor, Pressure, For I.V. Bags) and GCJ (Laparoscope, General & Plastic Surgery). 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Tecnadyne Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tecnadyne Scientific, 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?

  • KZDInfusor, Pressure, For I.V. Bags2decisions
  • GCJLaparoscope, General & Plastic Surgery2decisions
  • DXQBlood Pressure Cuff1decision

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.

  • K940891Tecnadyne Endoscopic Instrument HolderTecnadyne Scientific, Inc. · 19942cite it

What has FDA decided for it lately?

  • K940431Tecnadyne 20/20 Fog Inhibitor KitTecnadyne Scientific, Inc. · 1994
  • K940891Tecnadyne Endoscopic Instrument HolderTecnadyne Scientific, Inc. · 1994
  • K910926Tecnadyne Surgi-Squeeze Infusion PumpTecnadyne Scientific, Inc. · 1991
  • K912007Baxter Single Patient Use Blood Pressure CuffTecnadyne Scientific, Inc. · 1991
  • K904484Baxter Single Patient Use Pressure InfusorTecnadyne Scientific, Inc. · 1990

All 5 as Tecnadyne Scientific, Inc. →