# Masimo Corporation

- Location (FDA's records): Irvine, CA
- FDA decisions: 116 (1997–2026): 114 510(k) clearances and 2 De Novo grants
- Names in FDA's records: Masimo Corporation (88); Masimo Corp. (28)
- Product codes: DQA (77), MWI (13), MUD (6), MHX (4), DPS (3), OLW (3), NLF (2), QYU (1), QWE (1), OLK (1), BZQ (1), QVT (1)
- 510(k) review time since 2016: median 221 days, against 205 for FDA's reviews in the same codes and years (15 of 35 faster)
- Predicates its devices cite: 169 (126 its own); citations of its devices by later devices: 236 (126 its own)
- Recalls linked to its devices: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nellcor Puritan Bennett, Inc.: 5 (https://510kreport.com/company/nellcor-puritan-bennett)
- Nellcor, Inc.: 5 (https://510kreport.com/company/nellcor)
- Radiometer America, Inc.: 3 (https://510kreport.com/company/radiometer-america)
- GE Healthcare: 2 (https://510kreport.com/company/ge-healthcare)
- Withings: 2 (https://510kreport.com/company/withings)
- Welch Allyn, Inc.: 2 (https://510kreport.com/company/welch-allyn)
- Nonin Medical, Inc.: 2 (https://510kreport.com/company/nonin-medical)
- Phasein AB: 2 (https://510kreport.com/company/phasein)

## Firms that cite its devices most
- Sterilmed, Inc.: 7 (https://510kreport.com/company/sterilmed)
- Ge Medical Systems Information Technologies: 6 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Cas Medical Systems, Inc.: 5 (https://510kreport.com/company/cas-medical-systems)
- Orsense, Ltd.: 5 (https://510kreport.com/company/orsense)
- Philips Medical Systems, Inc.: 4 (https://510kreport.com/company/philips-medical-systems)
- Welch Allyn, Inc.: 4 (https://510kreport.com/company/welch-allyn)
- Draeger Medical Systems, Inc.: 4 (https://510kreport.com/company/draeger-medical-systems)
- Nonin Medical, Inc.: 3 (https://510kreport.com/company/nonin-medical)

## Its most-cited devices
- K031330: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables (2003), cited by 14
- K051212: Modification to LNCS Oximetry Sensors (2005), cited by 12
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V (2004), cited by 11
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter (2008), cited by 11
- K990966: Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-Pediatric/Small Dis (1999), cited by 10
- K041815: LNCS Oximetry Sensors (2004), cited by 9

## Recent decisions
- K260676: Radius VSM and Accessories (Oct 14, 2026)
- K253417: Masimo Root Monitoring System (Aug 12, 2026)
- K260880: SedLine Sedation Monitor (Jul 10, 2026)
- K254209: Radius VSM and Accessories (Jun 4, 2026)
- K243324: Masimo O3 Regional Oximeter (Jul 17, 2025)
- K250757: Radius VSM and Accessories (May 29, 2025)
- K243305: Masimo W1 (Apr 3, 2025)
- K240229: Masimo W1 (Aug 8, 2024)

Source page: https://510kreport.com/company/masimo