510(k) Report

FDA applicant

Diamond Medical, Inc.

St. Paul, MN6 decisions1987–19921 recall

FDA records 6 decisions for Diamond Medical, Inc. (St. Paul, MN) from 1987 to 1992: 6 510(k) clearances. Most are in product codes FFT (Electrode, Ph, Stomach) and CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…). 1 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 Diamond Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diamond Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diamond Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Diamond Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FFTElectrode, Ph, Stomach4decisions
  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph2decisions

What has FDA decided for it lately?

  • K924758Dmi Blood Gas Analyzer/CartridgeDiamond Medical, Inc. · 19921 recall
  • K915087Dmi Blod Gas Analyzer/CartridgeDiamond Medical, Inc. · 1992
  • K874710Diamond Medical, Inc. Model DM 600Diamond Medical, Inc. · 1988
  • K874709Diamond Medical, Inc. Model DM 800Diamond Medical, Inc. · 1988
  • K875369Model Iso-2001 Univ. Patient Isolation CircuitDiamond Medical, Inc. · 1988
  • K863298Diamond Medical, Inc., Model DM 700Diamond Medical, Inc. · 1987

All 6 as Diamond Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K924758IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number…Jul 14, 2003

Other applicant names beginning “Diamond”

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

Diamond Diagnostics, Inc. 26Diamond Sensor Systems 3Diamond Medical Equipment, Inc. 3Diamond Shamrock Corp. 2Diamond Electro-Tech, Inc. 1Diamond 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