K241036 is an FDA 510(k) clearance for the Autoclave Indicator Tape. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Jiangmen New Era External Use Drug Co., Ltd. (Jiangmen, CN). The FDA issued a Cleared decision on December 17, 2024, 245 days after receiving the submission on April 16, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K241036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2024 |
| Decision Date | December 17, 2024 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| 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 |