Submission Details
| 510(k) Number | K250061 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 2025 |
| Decision Date | February 06, 2025 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
Celerity Incubator
Feb 2025
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K250061 is an FDA 510(k) clearance for the Celerity 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 February 6, 2025, 27 days after receiving the submission on January 10, 2025. 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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