Submission Details
| 510(k) Number | K233681 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 16, 2023 |
| Decision Date | December 15, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
ConFirm 20 Minute Incubator
Dec 2023
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K233681 is an FDA 510(k) clearance for the ConFirm 20 Minute Incubator, a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on December 15, 2023, 29 days after receiving the submission on November 16, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.
Device Classification
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
Manufacturer
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