510(k) Report

FDA applicant

Medrange Corporation

Brea, CA3 decisions2010–20200 recalls

FDA records 3 decisions for Medrange Corporation (Brea, CA) from 2010 to 2020: 3 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medrange”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Medrange Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2010: 12012: 12020: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Medrange Corporation by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K102114Medrange Electrosurgical GeneratorMedrange Corporation · 20101cites it
  • K201224Electrosurgical Generator and AccessoriesMedrange · 20201cites it

What has FDA decided for it lately?

  • K201224Electrosurgical Generator and AccessoriesMedrange · 2020
  • K122092Medrange Electrosurgical Expansion SystemMedrange Corporation · 2012
  • K102114Medrange Electrosurgical GeneratorMedrange Corporation · 2010

All 2 as Medrange Corporation →The one decision as Medrange →