510(k) Report

FDA applicant

Diamond Electro-Tech, Inc.

Ann Arbor, MI1 decision1986–19860 recalls

FDA records 1 decision for Diamond Electro-Tech, Inc. (Ann Arbor, MI) in 1986: 1 510(k) clearance. All are in product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary…). 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, cardiovascular panel, where it files most

How often FDA has decided Diamond Electro-Tech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diamond Electro-Tech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diamond Electro-Tech, 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?

  • DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1decision

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.

  • K854357Gem-6, with ComponentsDiamond Electro-Tech, Inc. · 19861cites it

What has FDA decided for it lately?

  • K854357Gem-6, with ComponentsDiamond Electro-Tech, Inc. · 1986

The one decision as Diamond Electro-Tech, Inc. →

Other applicant names beginning “Diamond”

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

Diamond Diagnostics, Inc. 26Diamond Medical, Inc. 6Diamond Sensor Systems 3Diamond Medical Equipment, Inc. 3Diamond Shamrock Corp. 2Diamond Orthopedic, LLC 1Diamond Rotary and Carbide Intl. 1Diamond Systems USA, Inc. 1Diamond Age Systems, Inc. 1Diamond General Development Corp. 1Diamond Orthotic Laboratory 1Diamond Mark International Co., Ltd. 1