Masimo O3 Regional Oximeter
FDA 510(k) K243324 · Masimo Corporation
510(k) numberK243324
Submission
- Device name
- Masimo O3 Regional Oximeter
- Applicant
- Masimo Corporation
Irvine, CA, US - Received
- October 23, 2024
- Decision date
- July 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUD – Oximeter, Tissue Saturation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Other 510(k)s with product code MUD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254129 | Spectrum-2MUD · Traditional | Neko Health AB | 05/22/2026SE |
| K250519 | Lap.Ox Laparoscopic Tissue OximeterMUD · Traditional | ViOptix, Inc. | 06/26/2025SE |
| K240596 | Cerebral Autoregulation Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences | 10/16/2024SE |
| K241393 | ODI-TechMUD · Traditional | Odi Medical AS | 08/30/2024SE |
| K240601 | SnapshotNIR model KD205MUD · Traditional | Kent Imaging, Inc. | 04/02/2024SE |
| K232385 | OxiplexTS200MUD · Traditional | Iss Medical, Inc. | 03/01/2024SE |
| K233488 | Intra.Ox 2.0 Handheld Tissue OximeterMUD · Traditional | Vioptix, Inc. | 02/28/2024SE |
| K230612 | Edwards Algorithm for Measurement of Blood HemoglobinMUD · Traditional | Edwards Lifesciences, LLC | 11/17/2023SE |
| K223651 | Cerebral Adaptive Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences, LLC | 05/26/2023SE |
| K214072 | Masimo O3 Regional Oximeter SystemMUD · Traditional | Masimo Corporation | 05/06/2022SE |
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| K254209 | Radius VSM and AccessoriesMHX · Traditional | 06/04/2026SE |
| K250757 | Radius VSM and AccessoriesMHX · Traditional | 05/29/2025SE |
| K243305 | Masimo W1DPS · Traditional | 04/03/2025SE |
| K240229 | Masimo W1DPS · Traditional | 08/08/2024SE |
| K234021 | Masimo StorkQYU · Traditional | 05/03/2024SE |
| K214115 | MightySat -OTCOLK · Traditional | 01/31/2024SE |
| K223721 | Masimo StorkDQA · Traditional | 12/15/2023SE |
| K232512 | Masimo W1DPS · Traditional | 11/17/2023SE |
Questions and answers
When was Masimo O3 Regional Oximeter cleared by the FDA?
Masimo O3 Regional Oximeter (K243324) received a 510(k) decision of Substantially Equivalent on July 17, 2025, 267 days after the submission was received.
What is the product code of K243324?
The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.