K250802 is an FDA 510(k) clearance for the STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104). This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K250802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |