Hospital bedside pulse oximetry monitoring without patient face

Masimo patient monitoring

Masimo SpO2 accuracy you can specify. Sensors you can stock.

Masimo pulse oximeters, disposable and reusable SpO2 sensors, and bedside monitors for hospital, rehab, and home-care programs — with FDA-cleared pathways, CE marking under MDR 2017/745, and ISO 13485 lot traceability.

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Spec compare

Handheld vs bedside monitoring — pick by care setting

Compare SpO2 accuracy bands, waveform export, battery runtime, and EMR connectivity before you issue an RFP. Values below are representative catalog ranges; confirm the exact 510(k) summary and IFU for your market.

Parameter MightySat / Handheld SpO2 Radical / Bedside Monitor Family
Primary useSpot-check, transport, home healthContinuous ICU / ward / PACU monitoring
SpO2 accuracy (Arms, no motion)±2% (70–100% SpO2), adult/ped per IFU±2% (70–100% SpO2); motion/low-perfusion modes per cleared IFU
Sensor optionsReusable fingertip + select disposable LNCS-classDisposable LNCS / RD rainbow-ready + reusable
Battery / power≥14 h typical continuous spot-check dutyAC + battery backup ≥60 min full-load transport
ConnectivityBluetooth LE optional; FHIR Observation push via bridgeHL7 v2 ORU + FHIR R4 Observation; nurse-call relay
Alarm frameworkVisual SpO2 / PR thresholdsIEC 60601-1-8 priority alarms with smart delay options
Regulatory pathFDA 510(k) cleared; CE MDR Class IIa where marketedFDA 510(k) cleared; IEC 60601-1 / ISO 80601-2-61
UDI / lotUDI-DI on device + sensor packagingUDI-DI on monitor + each sensor lot

Arms = accuracy root mean square. Motion and low-perfusion claims apply only where the cleared IFU states them. Do not treat website tables as labeling.

Catalog families

Core Masimo device lines

Compact cards for procurement shortlists. Open Products for live category tabs and inquiry routing.

Why biomed teams shortlist Masimo

Lean features that survive value analysis

  • SpO2 accuracy with disclosed Arms bands

    Adult and pediatric Arms values published against ISO 80601-2-61 test methods. Motion and low-perfusion modes listed only when cleared — no unverified percentages.

  • UDI-DI + lot-level sensor traceability

    Every disposable SpO2 sensor ships with UDI-DI / GTIN labeling to support FDA UDI rule recall sweeps and hospital ERP replenishment.

  • HL7 FHIR Observation & HL7 v2 ORU paths

    Bedside families expose HL7 v2.5.1 ORU and FHIR R4 Observation for SpO2 / PR into Epic, Cerner, and MEDITECH without custom middleware when the site bridge is configured.

  • IEC 60601-1 electrical safety + EMC

    Monitor platforms designed under IEC 60601-1 and IEC 60601-1-2 EMC; MDS² and SBOM packages available for cybersecurity committees.

  • Home-to-hospital discharge bundles

    Handheld oximeters and caregiver teach-back kits align with hospital-to-home pathways, HCPCS review support, and 30-day check-in scripts.

  • Field service with MTTR targets

    Urban on-site response target under 4 hours for contracted Premium tiers; rural under 24 hours. Loaner monitors available during depot repair.

100+peer-reviewed SpO2 / SET-related publications cited in clinical dossiers*
50+countries with authorized biomedical service coverage
99.6%contracted uptime SLA on networked bedside fleets
2.4 hmedian MTTR on Premium service contracts (FY2024)

*Publication counts reference Masimo clinical dossiers and are not a ranking claim. Uptime/MTTR apply only under active service contracts.

Need the IFU, SpO2 Arms table, or a GPO quote pack?

Route a documentation request or schedule a clinical specialist review. We respond with market-specific clearance letters — never generic “FDA approved” language for 510(k) devices.

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