FDA applicant
Acme United Corp.
FDA records 27 decisions for Acme United Corp. (Mchenry, IL) from 1976 to 1996: 27 510(k) clearances. Most are in product codes KMF (Bandage, Liquid) and NAD (Dressing, Wound, Occlusive). Its devices cite 4 predicates, 4 of them its own earlier devices. 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 Acme United Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Acme United Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Acme United 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 “Acme”
FDA records each applicant name separately; these may or may not be the same firm.