K250061 is an FDA 510(k) clearance for the Celerity Incubator. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K250061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |