510(k) Report

FDA applicant

Metron U.S., Inc.

Grand Rapids, MI4 decisions1997–19980 recalls

FDA records 4 decisions for Metron U.S., Inc. (Grand Rapids, MI) from 1997 to 1998: 4 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and FRN (Pump, Infusion). 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 Metron U.S., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Metron U.S., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Metron U.S., 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?

  • DPSElectrocardiograph1decision
  • FRNPump, Infusion1decision
  • DQAOximeter1decision
  • DRLTester, Defibrillator1decision

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.

  • K963190QA-40M Defibrillator TesterMetron U.S., Inc. · 19971cites it

What has FDA decided for it lately?

  • K982020Metron QA-Ids I.V. Pump TesterMetron U.S., Inc. · 1998
  • K973991Metron QA-510 SPO2 AnalyzerMetron U.S., Inc. · 1998
  • K963190QA-40M Defibrillator TesterMetron U.S., Inc. · 1997
  • K963198PS-41 6M Patient SimulatorMetron U.S., Inc. · 1997

All 4 as Metron U.S., Inc. →

Other applicant names beginning “Metron”

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

Metron Medical Australia, Pty, Ltd. 17