Masimo SafetyNet
DEN200011Masimo Corporation · granted 2023-03-31 · product code QVT · Anesthesiology
Premarket evidence — what FDA accepted
source quote (p.1)
“A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose.”
source quote (p.3)
“Opioid Halo - Software that runs continuously to provide real-time detection of the severe OIRD risk based upon changes or patterns in oxygenation biomarker data (peripheral oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi)) found to be consistent with published understanding of physiological effects of OIRD.”
source quote (p.5)
“Software documentation including management of cybersecurity was provided in accordance with the FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," (issued May 11, 2005) for a Major Level of Concern (LOC).”
Validation studies (3)
Bench
sample size not stated
endpoints: verification of pulse oximeter monitoring functions; verification of general instrument functions; demonstrate wireless communication
Retrospective clinical
n=641 patients
endpoints: improved detection of opioid induced respiratory depression (OIRD); increased specificity in the detection of OIRD; reduction of non-actionable alarms; time from opioid injection to alarm (TFO); time from alarm to intervention (TTI)
Standalone
n=22 patients
endpoints: SpO2 performance validation; SpO2 Accuracy Range; ARMS Values
Reported performance (8 observations)
source quote (p.6)
“Overall 40322 641 130 99.2% 80.6% 100.0% 93.9% 100.0% 97.5% 79.2% 99.5%”
source quote (p.6)
“Overall 40322 641 130 99.2% 80.6% 100.0% 93.9% 100.0% 97.5% 79.2% 99.5%”
source quote (p.6)
“Overall 40322 641 130 99.2% 80.6% 100.0% 93.9% 100.0% 97.5% 79.2% 99.5%”
source quote (p.6)
“Overall 40322 641 130 99.2% 80.6% 100.0% 93.9% 100.0% 97.5% 79.2% 99.5%”
source quote (p.6)
“Overall 40322 641 130 99.2% 80.6% 100.0% 93.9% 100.0% 97.5% 79.2% 99.5%”
source quote (p.6)
“Overall 40322 641 130 99.2% 80.6% 100.0% 93.9% 100.0% 97.5% 79.2% 99.5%”
source quote (p.6)
“Overall 40322 641 130 99.2% 80.6% 100.0% 93.9% 100.0% 97.5% 79.2% 99.5%”
source quote (p.6)
“Overall 40322 641 130 99.2% 80.6% 100.0% 93.9% 100.0% 97.5% 79.2% 99.5%”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.
Predicate network
Postmarket — what happened after clearance
Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).
Applicable FDA guidance — what the submission is measured against
FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Anesthesiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.
- Final guidance2021-10De Novo Classification Process (Evaluation of Automatic Class III Designation)
De Novo pathway
Final (Oct 2021), issued with the De Novo final rule. Most relevant to first-of-a-kind devices without a predicate (DEN-numbered clearances).
- Draft guidanceAnesthesiology-specific2025-01Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations
Software premarket content
Draft (Jan 2025) on skin-pigmentation performance equity; relevant to AI-based SpO2 estimation. Still draft as of July 2026.
- Final guidance2026-01Clinical Decision Support Software
Clinical decision support · SaMD (general)
New final guidance issued Jan 2026, superseding the Sept 2022 version; narrows the device-CDS scope. Applies to software that informs clinical management.
- Final guidance2026-01General Wellness: Policy for Low Risk Devices
SaMD (general) · Clinical decision support
Revised final (Jan 2026); now addresses noninvasive products estimating physiologic parameters (SpO2, BP, glucose). Reshapes the device / non-device line for AI wellness features.
- Final guidance2025-09Computer Software Assurance for Production and Quality Management System Software
SaMD (general) · Postmarket
Final (Sept 2025). Covers software used in production/QMS (incl. ML development-pipeline tooling), superseding Section 6 of the 2002 GPSV — not device software functions themselves.
- Final guidance2025-06Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
Cybersecurity · Software premarket content
Reissued June 2025 (retitled 'Quality Management System', was Sept 2023 'Quality System'); adds coverage of FD&C Act §524B cyber devices.
- Final guidance2024-12Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Predetermined Change Control Plan · AI/ML lifecycle · Software premarket content
Final (Dec 2024). Supersedes the April 2023 AI/ML PCCP draft.
- Final guidance2023-10Electronic Submission Template for Medical Device 510(k) Submissions
Software premarket content
eSTAR has been mandatory for 510(k)s since Oct 2023 — operationally unavoidable, though not AI-specific.
- Final guidance2023-08Off-The-Shelf Software Use in Medical Devices
Software premarket content · SaMD (general)
Final (Aug 2023). Applies when a device incorporates off-the-shelf software components (common in ML stacks).
- Final guidance2023-06Content of Premarket Submissions for Device Software Functions
Software premarket content · SaMD (general)
Final (June 2023); replaced the May 2005 'Software Contained in Medical Devices' guidance. Documentation level drives the software content of the submission.
- Final guidance2022-09Policy for Device Software Functions and Mobile Medical Applications
SaMD (general) · Clinical decision support
Current version Sept 2022. Frames which software functions FDA regulates as devices.
- Final guidance2016-12Postmarket Management of Cybersecurity in Medical Devices
Cybersecurity · Postmarket
- Final guidance2002-01General Principles of Software Validation
SaMD (general) · Software premarket content
Still active except Section 6 (superseded Sept 2025 by the Computer Software Assurance final guidance).
- Draft guidance2025-01Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
AI/ML lifecycle · Software premarket content · Transparency
Draft as of July 2026 (published Jan 2025); finalization is on CDRH's FY2026 agenda but not yet published. Treat as FDA's stated direction, not a binding expectation.
- Draft guidance2024-08Predetermined Change Control Plans for Medical Devices
Predetermined Change Control Plan · Postmarket
Draft (Aug 2024) extending PCCPs beyond AI to all devices under FD&C §515C; not final as of July 2026.
- Guiding principles2024-06Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles
Transparency · AI/ML lifecycle
- Guiding principles2023-10Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
Predetermined Change Control Plan · AI/ML lifecycle
FDA/Health Canada/MHRA joint principles (Oct 2023); companion to the GMLP and Transparency principles.
- Guiding principles2021-10Good Machine Learning Practice for Medical Device Development: Guiding Principles
AI/ML lifecycle · SaMD (general)
FDA/Health Canada/MHRA joint principles (Oct 2021). Foundational, not a binding guidance; IMDRF issued a related GMLP document Jan 2025.
Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.