Submission Details
| 510(k) Number | K212174 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 2021 |
| Decision Date | October 09, 2021 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
STERRAD 100NX Sterilizer with ALLClear Technology
Oct 2021
Decision
89d
Days
Class 2
Risk
About This 510(k) Submission
K212174 is an FDA 510(k) clearance for the STERRAD 100NX Sterilizer 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 October 9, 2021, 89 days after receiving the submission on July 12, 2021. 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
K250802
· MLR · Apr 2025
K234084
· JOJ · Jul 2024
K220404
· MLR · May 2022