Data / Medical devices / United States / Masimo Corporation
Masimo Corporation: FDA-registered device maker in Irvine, CA, United States, 51 510(k) clearances
Masimo Corporation is registered with the FDA (registration 3011353843) in Irvine, CA, United States. It lists 42 device types. The FDA files 51 510(k) clearances under its listings, the newest dated August 12, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011353843
- Address
- 52 Discovery, Irvine, CA, United States, 92618
- Owner or operator
- MASIMO CORPORATION (9031881)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 30, 1999
- Registered through
- 2027
- Brand names listed
- AC-1 Adapter Cable, CareScape SpO2 - Masimo, Centroid, DBI-dc, Direct Connect Sensors, EMMA, EMMA Airway Adapter, IRMA AX+ and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 12, 2026 | K253417 | Masimo Root Monitoring System | MWI | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| April 3, 2025 | K243305 | Masimo W1 | DPS | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| May 3, 2024 | K234021 | Masimo Stork | QYU | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| December 15, 2023 | K223721 | Masimo Stork | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| October 12, 2023 | DEN200076 | ORi | QWE | Unknown | Masimo Corporation | accessdata.fda.gov |
| September 7, 2023 | K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| June 1, 2023 | K223498 | Radius VSM and Accessories | MHX | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| April 16, 2023 | K213676 | Masimo Rad-G with Temperature | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| March 6, 2023 | K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | MWI | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| May 6, 2022 | K214072 | Masimo O3 Regional Oximeter System | MUD | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| February 25, 2022 | K203113 | Masimo SedLine Sedation Monitor and Accessories | OLW | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| June 11, 2021 | K203215 | Radius T wearable thermometer | FLL | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| March 29, 2021 | K201590 | EMMA Capnograph | CCK | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| April 22, 2020 | K191882 | Masimo Centroid System | MWI | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| February 27, 2020 | 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 | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| December 27, 2019 | K191059 | Masimo Rad-97 and Accessories | MWI | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| May 15, 2019 | K183697 | Masimo Rad-97 and Accessories | MWI | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| March 22, 2019 | K182887 | Masimo Rad-67 Pulse CO-Oximeter and Accessories | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| January 23, 2019 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| October 23, 2018 | K180046 | Masimo Rad-97 and Accessories | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| September 5, 2018 | K173976 | Masimo Acoustic Respiration Sensors, infant and neonate | BZQ | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| November 17, 2017 | K171121 | Masimo Root Monitoring System and Accessories | MWI | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| June 5, 2017 | K163334 | LiDCOunity v2 Hemodynamic Monitor | DXG | Substantially Equivalent | Lidco, Ltd. | accessdata.fda.gov |
| November 23, 2016 | K160940 | Masimo Disposable Transflectance Forehead Sensor | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| April 26, 2013 | K120984 | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| October 25, 2012 | K123043 | IRMA C02 MODEL 200101; IRMA AX 200601 | CCK | Substantially Equivalent | Phasein AB | accessdata.fda.gov |
| September 7, 2012 | K121914 | MASIMO SET USPO2 PULSE OXIMETRY CABLE | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 24, 2012 | K121912 | E1 EAR SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| February 24, 2012 | K113596 | MASIMO SET REUSABLE OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| September 23, 2011 | K111888 | MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 28, 2011 | K110723 | M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS | NLF | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| October 21, 2010 | K101896 | MASIMO LNCS/M-LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| May 14, 2010 | K094046 | LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 9, 2009 | K091057 | MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 9, 2009 | K090165 | RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| April 2, 2009 | K083622 | LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| October 10, 2008 | K082052 | MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| September 9, 2008 | K081659 | RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| May 12, 2008 | K080238 | MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| June 29, 2007 | K071024 | MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| June 8, 2007 | K071047 | MASIMO PATIENT SAFETY NET | MSX | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| March 16, 2006 | K053477 | MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 15, 2005 | K051439 | LNOP BLUE OXIMETRY SENSOR | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 12, 2005 | K051212 | MODIFICATION TO LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| May 11, 2005 | K050252 | AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 29, 2004 | K041815 | LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corp. | accessdata.fda.gov |
| June 29, 2004 | K041204 | NC SP02 ADAPTER CABLE | DQA | Substantially Equivalent | Masimo Corp. | accessdata.fda.gov |
| April 22, 2004 | K040259 | MASIMO SET INTELLIVUE PULSE OXIMETER MODULE | DQA | Substantially Equivalent | Masimo Corp. | accessdata.fda.gov |
| March 19, 2004 | K033998 | MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V | DQA | Substantially Equivalent | Masimo Corp. | accessdata.fda.gov |
| February 25, 2004 | K040214 | MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | DQA | Substantially Equivalent | Masimo Corp. | accessdata.fda.gov |
| December 12, 2003 | K033298 | SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS | DQA | Substantially Equivalent | Masimo Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 20, 2026 | 98481 | Class II | Ongoing | Radius VSM ECG pre-connected Set, REF: 4842, 4695 | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges | accessdata.fda.gov |
| February 15, 2024 | 94170 | Class II | Ongoing | 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. | accessdata.fda.gov |
| April 21, 2023 | 92371 | Class II | Ongoing | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 | TC-I tip clip sensor may produce readings outside the accuracy specification. | accessdata.fda.gov |
Compare with other makers
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Updated August 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.