K242189 is an FDA 510(k) clearance for the CELERITY HP Indicator Tape (PCC077). This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on August 20, 2024, 26 days after receiving the submission on July 25, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K242189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2024 |
| Decision Date | August 20, 2024 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |