K243324 is an FDA 510(k) clearance for the Masimo O3 Regional Oximeter, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on July 17, 2025, 267 days after receiving the submission on October 23, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K243324 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 23, 2024 |
| Decision Date | July 17, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MUD — Oximeter, Tissue Saturation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2700 |