Masimo Corporation
FDA Regulatory Profile
Masimo Corporation appears in FDA public data with 13 recalls, 87 510(k) clearances, 8 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2670-2026, Class II) was initiated on Feb 20, 2026. Its most recent 510(k) clearance was granted on Aug 12, 2026.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 87
- Inspections
- 8
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2670-2026 | Class II | Radius VSM ECG pre-connected Set, REF: 4842, 4695 | Feb 20, 2026 |
| Z-2671-2026 | Class II | Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 | Feb 20, 2026 |
| Z-1536-2024 | Class II | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, | Feb 15, 2024 |
| Z-1537-2024 | Class II | Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, | Feb 15, 2024 |
| Z-1538-2024 | Class II | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, | Feb 15, 2024 |
| Z-1539-2024 | Class II | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, | Feb 15, 2024 |
| Z-1986-2023 | Class II | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 | Apr 21, 2023 |
| Z-1983-2023 | Class II | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 | Apr 21, 2023 |
| Z-1984-2023 | Class II | Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 | Apr 21, 2023 |
| Z-1985-2023 | Class II | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 | Apr 21, 2023 |
| Z-0338-2016 | Class II | rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/S | Oct 28, 2015 |
| Z-0213-2015 | Class II | Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides | Sep 30, 2014 |
| Z-1187-2013 | Class II | Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the | Mar 13, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253417 | Masimo Root Monitoring System | Aug 12, 2026 |
| K260880 | SedLine Sedation Monitor | Jul 10, 2026 |
| K254209 | Radius VSM and Accessories | Jun 4, 2026 |
| K243324 | Masimo O3 Regional Oximeter | Jul 17, 2025 |
| K250757 | Radius VSM and Accessories | May 29, 2025 |
| K243305 | Masimo W1 | Apr 3, 2025 |
| K240229 | Masimo W1 | Aug 8, 2024 |
| K234021 | Masimo Stork | May 3, 2024 |
| K214115 | MightySat -OTC | Jan 31, 2024 |
| K223721 | Masimo Stork | Dec 15, 2023 |
| K232512 | Masimo W1 | Nov 17, 2023 |
| DEN200076 | ORi | Oct 12, 2023 |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | Sep 7, 2023 |
| K223498 | Radius VSM and Accessories | Jun 1, 2023 |
| K213676 | Masimo Rad-G with Temperature | Apr 16, 2023 |
| DEN200011 | Masimo SafetyNet | Mar 31, 2023 |
| K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | Mar 6, 2023 |
| K221953 | Masimo CARESCAPE SpO2 Masimo with SpHb | Aug 4, 2022 |
| K214072 | Masimo O3 Regional Oximeter System | May 6, 2022 |
| K203113 | Masimo SedLine Sedation Monitor and Accessories | Feb 25, 2022 |