510(k) Report

FDA applicant

Fluke Biomedical

Cleveland, OH6 decisions2008–20130 recalls

FDA records 6 decisions for Fluke Biomedical (Cleveland, OH) from 2008 to 2013: 6 510(k) clearances. Most are in product codes DRT (Monitor, Cardiac (Incl. Cardiotachometer &…) and DRL (Tester, Defibrillator). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Fluke Biomedical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 22011: 22012: 12013: 1
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Fluke Biomedical by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)4decisions
  • DRLTester, Defibrillator2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K083347Impulse 7010 Defibrillator Selectable LoadsFluke Biomedical · 20081cites it
  • K072114Impulse 6000D/7000DPFluke Biomedical · 20081cites it

What has FDA decided for it lately?

  • K121860ESA615Fluke Biomedical · 2013
  • K121722ESA620 Electrical Safety AnalyzerFluke Biomedical · 2012
  • K110429Prosim 4, Prosim 6, Prosim 8Fluke Biomedical · 2011
  • K103336MPS450 Multiparameter SimulatorFluke Biomedical · 2011
  • K083347Impulse 7010 Defibrillator Selectable LoadsFluke Biomedical · 2008
  • K072114Impulse 6000D/7000DPFluke Biomedical · 2008

All 6 as Fluke Biomedical →