K210481 is an FDA 510(k) clearance for the Instant 20s Indicator, a Indicator, Chemical, Enzymatic, Sterilization Process (Class II — Special Controls, product code MTC), submitted by True Indicating, LLC (Toledo, US). The FDA issued a Cleared decision on December 14, 2021, 298 days after receiving the submission on February 19, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K210481 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 2021 |
| Decision Date | December 14, 2021 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MTC — Indicator, Chemical, Enzymatic, Sterilization Process |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |