Submission Details
| 510(k) Number | K222615 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 30, 2022 |
| Decision Date | September 28, 2022 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
Sep 2022
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K222615 is an FDA 510(k) clearance for the SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate, a Sterilant, Medical Devices (Class II — Special Controls, product code MED), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on September 28, 2022, 29 days after receiving the submission on August 30, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6885.
Device Classification
| Product Code | MED — Sterilant, Medical Devices |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6885 |
Manufacturer
Similar Devices — MED Sterilant, Medical Devices
All 62
K232914 · STERIS Corporation
· Oct 2023
K230582 · STERIS Corporation
· Mar 2023
K211607 · STERIS Corporation
· Sep 2021
K210737 · STERIS Corporation
· May 2021
K192929 · STERIS Corporation
· Dec 2019
K191343 · STERIS Corporation
· Sep 2019
More from STERIS Corporation
View all
K252680
· FRC · Sep 2025
K251048
· JOJ · May 2025
K243876
· JOJ · Apr 2025
K250842
· PKL · Apr 2025
K250044
· FRC · Feb 2025