FDA applicant
Sunbeam Corp.
FDA records 3 decisions for Sunbeam Corp. (Mchenry, IL) from 1978 to 1984: 3 510(k) clearances. Most are in product codes IME (Pack, Hot Or Cold, Reusable) and KFZ (Humidifier, Non-Direct Patient Interface…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sunbeam Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sunbeam Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sunbeam Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sunbeam”
FDA records each applicant name separately; these may or may not be the same firm.