Irvine, CA, US · 28 510(k) clearances · 8 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQA | — | — | — | 6 | 2023-12-15 |
| MWI | — | — | — | 5 | 2026-08-12 |
| MHX | — | — | — | 3 | 2026-06-04 |
| MUD | — | — | — | 3 | 2025-07-17 |
| DPS | Electrocardiograph | Class II | Cardiovascular | 3 | 2025-04-03 |
| OLW | Index-Generating Electroencephalograph Software | Class II | Neurology | 2 | 2026-07-10 |
| QYU | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use | Class II | Cardiovascular | 1 | 2024-05-03 |
| OLK | Pulse Oximeter For Over-The-Counter Use | Class II | Cardiovascular | 1 | 2024-01-31 |
| QWE | — | — | — | 1 | 2023-10-12 |
| QVT | Monitor For Opioid Induced Impairment Of Oxygenation | Class II | Anesthesiology | 1 | 2023-03-31 |
| FLL | Continuous Measurement Thermometer | Class II | General Hospital | 1 | 2021-06-11 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class II | Anesthesiology | 1 | 2021-03-29 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-02-15 | Class II | Ongoing | Z-1539-2024 | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, | — | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. |
| 2024-02-15 | Class II | Ongoing | Z-1538-2024 | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, | — | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. |
| 2024-02-15 | Class II | Ongoing | Z-1537-2024 | Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, | — | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. |
| 2024-02-15 | Class II | Ongoing | Z-1536-2024 | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, | — | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. |
| 2023-04-21 | Class II | Ongoing | Z-1986-2023 | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 | — | TC-I tip clip sensor may produce readings outside the accuracy specification. |
| 2023-04-21 | Class II | Ongoing | Z-1985-2023 | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 | — | TC-I tip clip sensor may produce readings outside the accuracy specification. |
| 2023-04-21 | Class II | Ongoing | Z-1984-2023 | Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 | — | TC-I tip clip sensor may produce readings outside the accuracy specification. |
| 2023-04-21 | Class II | Ongoing | Z-1983-2023 | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 | — | TC-I tip clip sensor may produce readings outside the accuracy specification. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-12 | K253417 | Masimo Root Monitoring System | MWI | — | — |
| 2026-07-10 | K260880 | SedLine Sedation Monitor | OLW | Class II | Neurology |
| 2026-06-04 | K254209 | Radius VSM and Accessories | MHX | — | — |
| 2025-07-17 | K243324 | Masimo O3 Regional Oximeter | MUD | — | — |
| 2025-05-29 | K250757 | Radius VSM and Accessories | MHX | — | — |
| 2025-04-03 | K243305 | Masimo W1 | DPS | Class II | Cardiovascular |
| 2024-08-08 | K240229 | Masimo W1 | DPS | Class II | Cardiovascular |
| 2024-05-03 | K234021 | Masimo Stork | QYU | Class II | Cardiovascular |
| 2024-01-31 | K214115 | MightySat -OTC | OLK | Class II | Cardiovascular |
| 2023-12-15 | K223721 | Masimo Stork | DQA | — | — |
| 2023-11-17 | K232512 | Masimo W1 | DPS | Class II | Cardiovascular |
| 2023-10-12 | DEN200076 | ORi | QWE | — | — |
| 2023-09-07 | K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | DQA | — | — |
| 2023-06-01 | K223498 | Radius VSM and Accessories | MHX | — | — |
| 2023-04-16 | K213676 | Masimo Rad-G with Temperature | DQA | — | — |
| 2023-03-31 | DEN200011 | Masimo SafetyNet | QVT | Class II | Anesthesiology |
| 2023-03-06 | K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | MWI | — | — |
| 2022-08-04 | K221953 | Masimo CARESCAPE SpO2 Masimo with SpHb | DQA | — | — |
| 2022-05-06 | K214072 | Masimo O3 Regional Oximeter System | MUD | — | — |
| 2022-02-25 | K203113 | Masimo SedLine Sedation Monitor and Accessories | OLW | Class II | Neurology |
| 2021-10-08 | K212876 | Carescape SpO2 - Masimo | DQA | — | — |
| 2021-06-11 | K203215 | Radius T wearable thermometer | FLL | Class II | General Hospital |
| 2021-03-29 | K201590 | EMMA Capnograph | CCK | Class II | Anesthesiology |
| 2020-09-24 | K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor | DQA | — | — |
| 2020-08-29 | K201432 | Masimo O3 Regional Oximeter System | MUD | — | — |
| 2020-08-10 | K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | MWI | — | — |
| 2020-04-22 | K191882 | Masimo Centroid System | MWI | — | — |
| 2020-02-27 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories | MWI | — | — |