510(k) Report

FDA applicant

Burton Medical Products Corp.

Van Nuys, CA15 decisions1985–20101 recall

FDA records 15 decisions for Burton Medical Products Corp. (Van Nuys, CA) from 1985 to 2010: 15 510(k) clearances. Most are in product codes KZF (Device, Medical Examination, Ac Powered) and FSY (Light, Surgical, Ceiling Mounted). Its devices cite 1 predicate, 1 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Burton Medical Products Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Burton Medical Products Corp.’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?

  • KZFDevice, Medical Examination, Ac Powered7decisions
  • FSYLight, Surgical, Ceiling Mounted5decisions
  • FTDLamp, Surgical2decisions
  • FTALight, Surgical, Accessories1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K042395Outpatient Iii Minor Surgery LightBurton Medical Products Corp. · 20042cite it
  • K101537Aim 200, Major Surgical LightBurton Medical Products Corp. · 20101cites it

What has FDA decided for it lately?

  • K101537Aim 200, Major Surgical LightBurton Medical Products Corp. · 2010
  • K042395Outpatient Iii Minor Surgery LightBurton Medical Products Corp. · 2004
  • K000639Visionary 2000Burton Medical Products Corp. · 2000
  • K963682Genie' Single Ceiling and Double CeilingBurton Medical Products Corp. · 1996
  • K961843GENIEBurton Medical Products Corp. · 1996
  • K935102Saturn LightBurton Medical Products Corp. · 1994
  • K942553GenesisBurton Medical Products Corp. · 1994
  • K936088Wave Fluorescent MagnifierBurton Medical Products Corp. · 1994

All 15 as Burton Medical Products Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K851742All Outpatient and Coolspot single ceiling or single track Medical Examination Lights…Feb 19, 2004

Other applicant names beginning “Burton”

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

Burton Parsons & Co., Inc. 1Burton 1