510(k) Report

FDA applicant

Northern Electric Co. Div. of Sunbeam Corp.

Chicago, IL4 decisions1985–19860 recalls

FDA records 4 decisions for Northern Electric Co. Div. of Sunbeam Corp. (Chicago, IL) from 1985 to 1986: 4 510(k) clearances. Most are in product codes KFZ (Humidifier, Non-Direct Patient Interface…) and EFS (Unit, Oral Irrigation). 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, dental panel, where it files most

How often FDA has decided Northern Electric Co. Div. of Sunbeam Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Northern Electric Co. Div. of Sunbeam Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Northern Electric Co. Div. of Sunbeam Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Northern Electric Co. Div. of Sunbeam…’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?

  • KFZHumidifier, Non-Direct Patient Interface (Home-Use)1decision
  • EFSUnit, Oral Irrigation1decision
  • EFTCleanser, Denture, Over The Counter1decision
  • JEQToothbrush, Powered1decision

What has FDA decided for it lately?

  • K860118Sunbeam Ultrasonic Denture Cleaner Model 4220Northern Electric Co. Div. of Sunbeam Corp. · 1986
  • K851220Sunbeam Evaporative Humidifier 663 & 664Northern Electric Co. Div. of Sunbeam Corp. · 1985
  • K852593Sunbeam Dental Care Center, Model NO. 6273Northern Electric Co. Div. of Sunbeam Corp. · 1985
  • K852279Sunbeam Rechargeable Toothbrush Model # 4201Northern Electric Co. Div. of Sunbeam Corp. · 1985

All 4 as Northern Electric Co. Div. of Sunbeam Corp. →