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Advanced Sterilization Products, Inc.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories2
Latest FDA decision2026-04-15
TypeNumberDevice NameCodeDateActions
510(k) K252843 STERRAD 100NX Sterilization System with ALLClear Technology (10104)MLR2026-04-15 View
510(k) K250802 STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)MLR2025-04-14 View
510(k) K234084 STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)JOJ2024-07-05 View
510(k) K220404 STERRAD NX with ALLClear TechnologyMLR2022-05-16 View
510(k) K212174 STERRAD 100NX Sterilizer with ALLClear TechnologyMLR2021-10-09 View