Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Northern Electric Co. Div. of Sunbeam Corp. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860118 | SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 | Northern Electric Co. Div. of Sunbeam Corp. | 1986-04-17 | 94 | 0 |
| K851220 | SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 | Northern Electric Co. Div. of Sunbeam Corp. | 1985-09-17 | 175 | 0 |
| K852593 | SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 | Northern Electric Co. Div. of Sunbeam Corp. | 1985-07-24 | 35 | 0 |
| K852279 | SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201 | Northern Electric Co. Div. of Sunbeam Corp. | 1985-07-01 | 33 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda