FDA applicant
STERIS Corporation
FDA records 228 decisions for STERIS Corporation (Mentor, OH) from 1997 to 2026: 224 510(k) clearances and 4 De Novo grants. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and FRC (Indicator, Biological Sterilization Process). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 290 predicates, 201 of them its own earlier devices. 44 recalls are linked to its devices.
FDA’s records also spell it “Steris”, “Steris Corp”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided STERIS Corporation’s devices, and how often a recall has named them.
FDA decisions per year
8in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like STERIS Corporation’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 “STERIS”
FDA records each applicant name separately; these may or may not be the same firm.