510(k) Report

FDA applicant

Masimo Corporation

Irvine, CA116 decisions1997–202619 recalls

FDA records 116 decisions for Masimo Corporation (Irvine, CA) from 1997 to 2026: 114 510(k) clearances and 2 De Novo grants. Most are in product codes DQA (Oximeter) and MWI (Monitor, Physiological, Patient (Without…). Since 2016 its 510(k)s took a median of 221 days from receipt to decision, against 205 for FDA’s reviews in the same codes and years. Its devices cite 169 predicates, 126 of them its own earlier devices. 19 recalls are linked to its devices.

FDA’s records also spell it “Masimo Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Masimo Corporation’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2007: 22008: 42009: 72010: 62011: 52012: 42013: 12014: 22015: 12016: 52017: 32018: 32019: 52020: 52021: 32022: 32023: 82024: 32025: 32026 (partial year): 4
2007high 8 (2023) · low 1 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2026

2010: 12014: 12015: 12016: 42023: 42024: 42026 (partial year): 2
2007high 4 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Masimo Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Masimo Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQAOximeter77decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)13decisions
  • MUDOximeter, Tissue Saturation6decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)4decisions
  • DPSElectrocardiograph3decisions
  • OLWIndex-Generating Electroencephalograph Software3decisions

Also: NLF (2), QYU (1), QWE (1), OLK (1), BZQ (1), QVT (1).

How long do its 510(k) reviews take?

Since 2016, its 35 510(k)s took a median of 221 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 205 days; 15 of its 35 were faster than that.

Whose devices does it build on?

Its devices cite 169 predicates; 126 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 236 times; 126 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K031330Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesMasimo Corp. · 200314cite it
  • K051212Modification to LNCS Oximetry SensorsMasimo Corporation · 200512cite it
  • K033296Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5VMasimo Corp. · 200411cite it
  • K080238Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-OximeterMasimo Corporation · 200811cite it
  • K990966Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop…Masimo Corp. · 199910cite it
  • K041815LNCS Oximetry SensorsMasimo Corp. · 20049cite it

What has FDA decided for it lately?

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K253417Masimo Root Monitoring SystemMasimo Corporation · 2026
  • K260880SedLine Sedation MonitorMasimo Corporation · 2026
  • K254209Radius VSM and AccessoriesMasimo Corporation · 2026
  • K243324Masimo O3 Regional OximeterMasimo Corporation · 2025
  • K250757Radius VSM and AccessoriesMasimo Corporation · 2025
  • K243305Masimo W1Masimo Corporation · 2025
  • K240229Masimo W1Masimo Corporation · 2024

All 88 as Masimo Corporation →All 28 as Masimo Corp. →

What has been recalled?

19 recalls linked to its devices; the latest:

  • K223498Radius VSM ECG pre-connected Set, REF: 4842, 4695Feb 20, 2026Class II
  • K223498Radius VSM Disposable NIBP Cuff, REF: 4825, 4826Feb 20, 2026Class II
  • K201770Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,Feb 15, 2024Class II
  • K201770Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,Feb 15, 2024Class II
  • K213676Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,Feb 15, 2024Class II
  • K213676Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,Feb 15, 2024Class II