Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Masimo Corporation — Predicate Candidate Screening
86 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
290 days90th percentile
86clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260880 | SedLine Sedation Monitor | Masimo Corporation | 2026-07-10 | 115 | 0 |
| K254209 | Radius VSM and Accessories | Masimo Corporation | 2026-06-04 | 157 | 0 |
| K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | 2025-07-17 | 267 | 0 |
| K250757 | Radius VSM and Accessories | Masimo Corporation | 2025-05-29 | 78 | 0 |
| K243305 | Masimo W1 | Masimo Corporation | 2025-04-03 | 164 | 0 |
| K240229 | Masimo W1 | Masimo Corporation | 2024-08-08 | 192 | 0 |
| K234021 | Masimo Stork | Masimo Corporation | 2024-05-03 | 135 | 0 |
| K214115 | MightySat -OTC | Masimo Corporation | 2024-01-31 | 762 | 0 |
| K223721 | Masimo Stork | Masimo Corporation | 2023-12-15 | 368 | 0 |
| K232512 | Masimo W1 | Masimo Corporation | 2023-11-17 | 91 | 0 |
| DEN200076 | ORi | Masimo Corporation | 2023-10-12 | 1025 | 0 |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | Masimo Corporation | 2023-09-07 | 29 | 0 |
| K223498 | Radius VSM and Accessories | Masimo Corporation | 2023-06-01 | 192 | 2 |
| K213676 | Masimo Rad-G with Temperature | Masimo Corporation | 2023-04-16 | 510 | 2 |
| DEN200011 | Masimo SafetyNet | Masimo Corporation | 2023-03-31 | 1136 | 0 |
| K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Acce | Masimo Corporation | 2023-03-06 | 602 | 0 |
| K221953 | Masimo CARESCAPE SpO2 – Masimo with SpHb | Masimo Corporation | 2022-08-04 | 30 | 0 |
| K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2022-05-06 | 130 | 0 |
| K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | 2022-02-25 | 498 | 0 |
| K212876 | Carescape SpO2 - Masimo | Masimo Corporation | 2021-10-08 | 29 | 0 |
| K203215 | Radius T wearable thermometer | Masimo Corporation | 2021-06-11 | 221 | 0 |
| K201590 | EMMA Capnograph | Masimo Corporation | 2021-03-29 | 290 | 0 |
| K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo | Masimo Corporation | 2020-09-24 | 87 | 2 |
| K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020-08-29 | 89 | 0 |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2020-08-10 | 228 | 0 |
| K191882 | Masimo Centroid System | Masimo Corporation | 2020-04-22 | 282 | 0 |
| K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radi | Masimo Corporation | 2020-02-27 | 94 | 0 |
| K191059 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019-12-27 | 249 | 0 |
| K182429 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2019-06-07 | 274 | 0 |
| K183697 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019-05-15 | 135 | 0 |
| K182887 | Masimo Rad-67 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2019-03-22 | 158 | 0 |
| K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019-01-23 | 184 | 0 |
| K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018-10-23 | 288 | 1 |
| K173976 | Masimo Acoustic Respiration Sensors, infant and neonate | Masimo Corporation | 2018-09-05 | 250 | 0 |
| K172890 | SedLine Sedation Monitor | Masimo Corporation | 2018-01-26 | 126 | 0 |
| K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017-11-17 | 214 | 0 |
| K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017-09-14 | 238 | 0 |
| K162603 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2017-05-26 | 249 | 0 |
| K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter | Masimo Corporation | 2016-12-28 | 93 | 0 |
| K160940 | Masimo Disposable Transflectance Forehead Sensor | Masimo Corporation | 2016-11-23 | 233 | 0 |
| K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2016-06-21 | 228 | 0 |
| K160526 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2016-06-09 | 105 | 0 |
| K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016-02-12 | 239 | 0 |
| K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015-10-22 | 255 | 0 |
| K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014-11-25 | 90 | 0 |
| K140188 | MASIMO ROOT MONITORING SYSTEM | Masimo Corporation | 2014-06-25 | 152 | 0 |
| K120984 | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR | Masimo Corporation | 2013-04-26 | 389 | 0 |
| K120657 | MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSOR | Masimo Corporation | 2012-09-19 | 198 | 0 |
| K121914 | MASIMO SET USPO2 PULSE OXIMETRY CABLE | Masimo Corporation | 2012-09-07 | 67 | 1 |
| K121912 | E1 EAR SENSORS | Masimo Corporation | 2012-07-24 | 22 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda