Data / Medical devices / United States / Masimo Corporation
Masimo Corporation: FDA-registered device maker in Irvine, CA, United States, 17 510(k) clearances
Masimo Corporation is registered with the FDA (registration 3009831876) in Irvine, CA, United States. It lists 32 device types. The FDA files 17 510(k) clearances under its listings, the newest dated September 7, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009831876
- Address
- 9600 Jeronimo, Irvine, CA, United States, 92618
- Owner or operator
- MASIMO CORPORATION (9031881)
- Roles
- Repackager or relabeler
- First device listed
- December 30, 1999
- Registered through
- 2027
- Brand names listed
- CareScape SpO2 - Masimo, Direct Connect Sensors, ISA AX+ Module, ISA CO2 Module, IntelliVue Module, LNCS Patient Cables, LNCS Reusable Sensors, LNCS TF-I 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| April 26, 2013 | K120984 | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| September 7, 2012 | K121914 | MASIMO SET USPO2 PULSE OXIMETRY CABLE | 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 9, 2009 | K091057 | MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES | 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 |
| 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 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 12, 2005 | K051212 | MODIFICATION TO LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 29, 2004 | K041815 | LNCS OXIMETRY SENSORS | 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 |
| 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 |
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Updated September 7, 2023. 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.