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Masimo Corporation

FDA 510(k) & PMA Approved Devices — 42 products

Total Devices42
Categories11
Latest FDA decision2026-08-12
TypeNumberDevice NameCodeDateActions
510(k) K253417 Masimo Root Monitoring SystemMWI2026-08-12 View
510(k) K260880 SedLine Sedation MonitorOLW2026-07-10 View
510(k) K254209 Radius VSM and AccessoriesMHX2026-06-04 View
510(k) K243324 Masimo O3 Regional OximeterMUD2025-07-17 View
510(k) K250757 Radius VSM and AccessoriesMHX2025-05-29 View
510(k) K243305 Masimo W1DPS2025-04-03 View
510(k) K240229 Masimo W1DPS2024-08-08 View
510(k) K234021 Masimo StorkQYU2024-05-03 View
510(k) K214115 MightySat -OTCOLK2024-01-31 View
510(k) K223721 Masimo StorkDQA2023-12-15 View
510(k) K232512 Masimo W1DPS2023-11-17 View
510(k) K232389 Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueDQA2023-09-07 View
510(k) K223498 Radius VSM and AccessoriesMHX2023-06-01 View
510(k) K213676 Masimo Rad-G with TemperatureDQA2023-04-16 View
510(k) K212161 Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMWI2023-03-06 View
510(k) K221953 Masimo CARESCAPE SpO2 – Masimo with SpHbDQA2022-08-04 View
510(k) K214072 Masimo O3 Regional Oximeter SystemMUD2022-05-06 View
510(k) K203113 Masimo SedLine Sedation Monitor and AccessoriesOLW2022-02-25 View
510(k) K212876 Carescape SpO2 - MasimoDQA2021-10-08 View
510(k) K203215 Radius T wearable thermometerFLL2021-06-11 View

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Related Clinical Trials

NCT02986789Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical OutcomesTERMINATEDNCT03706430Validation of RPVi as a Parameter to Predict Fluid ResponsivenessTERMINATEDNCT06289556Clinical Performance of Masimo INVSENSOR00048TERMINATEDNCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETEDNCT06922461Clinical Performance of Masimo INVSENSOR00048 (DALI0001)TERMINATEDNCT07223164Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular DiseaseCOMPLETEDNCT07223177Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric PopulationsRECRUITINGNCT05977686Hemoglobin Testing in Pregnant PatientsRECRUITINGNCT06148623Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin PigmentationCOMPLETEDNCT06232876Continuous Versus Intermittent Ward MonitoringRECRUITING
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