Submission Details
| 510(k) Number | K160818 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 24, 2016 |
| Decision Date | September 27, 2016 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
STERRAD? NX Sterilizer with ALLClear? Technology
Sep 2016
Decision
187d
Days
Class 2
Risk
About This 510(k) Submission
K160818 is an FDA 510(k) clearance for the STERRAD? NX Sterilizer with ALLClear? Technology, a Sterilizer, Chemical (Class II — Special Controls, product code MLR), submitted by Advanced Sterilization Products (Irvine, US). The FDA issued a Cleared decision on September 27, 2016, 187 days after receiving the submission on March 24, 2016. 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
Similar Devices — MLR Sterilizer, Chemical
All 45
K250802 · Advanced Sterilization Products, Inc.
· Apr 2025
K231893 · Lowtem Co., Ltd.
· Sep 2024
K234082 · Advanced Sterilization Products
· Jul 2024
K233762 · Ideate Medical, Inc.
· Jun 2024
K233065 · Steris
· Oct 2023
K223476 · STERIS Corporation
· Aug 2023
More from Advanced Sterilization...
View all
K234082
· MLR · Jul 2024
K163598
· KCT · Jul 2017
K162007
· MLR · Feb 2017
K160903
· MLR · Sep 2016
K151725
· MLR · Jan 2016