Cleared Traditional

STERRAD? 100NX Sterilizer with ALLClear? Technology (10104)

K250802 · Advanced Sterilization Products, Inc. · General Hospital
Apr 2025
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K250802 is an FDA 510(k) clearance for the STERRAD? 100NX Sterilizer with ALLClear? Technology (10104), a Sterilizer, Chemical (Class II — Special Controls, product code MLR), submitted by Advanced Sterilization Products, Inc. (Irvin, US). The FDA issued a Cleared decision on April 14, 2025, 31 days after receiving the submission on March 14, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.

Submission Details

510(k) Number K250802 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2025
Decision Date April 14, 2025
Days to Decision 31 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MLR — Sterilizer, Chemical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6860

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