FDA applicant
Advanced Sterilization Products
FDA records 59 decisions for Advanced Sterilization Products (Irvin, CA) from 1994 to 2026: 59 510(k) clearances. Most are in product codes MLR (Sterilizer, Chemical) and FRC (Indicator, Biological Sterilization Process). Since 2016 its 510(k)s took a median of 196 days from receipt to decision, against 183 for FDA’s reviews in the same codes and years. Its devices cite 67 predicates, 60 of them its own earlier devices. 52 recalls are linked to its devices.
FDA’s records also spell it “Advanced Sterilization Products, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Advanced Sterilization Products’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Advanced Sterilization Products’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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