Submission Details
| 510(k) Number | K220404 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 2022 |
| Decision Date | May 16, 2022 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
STERRAD NX with ALLClear Technology
May 2022
Decision
91d
Days
Class 2
Risk
About This 510(k) Submission
K220404 is an FDA 510(k) clearance for the STERRAD NX with ALLClear Technology, 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 May 16, 2022, 91 days after receiving the submission on February 14, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.
Device Classification
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6860 |
Manufacturer
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