FDA applicant
Steritec Products Mfg Co, Inc.
FDA records 22 decisions for Steritec Products Mfg Co, Inc. (Castle Rock, CO) from 1996 to 2020: 22 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and FRC (Indicator, Biological Sterilization Process). Its devices cite 6 predicates, 1 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Steritec Products Mfg Co, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Steritec Products Mfg Co, Inc.’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 “Steritec”
FDA records each applicant name separately; these may or may not be the same firm.