RX-1 Sleep
K253148Vivaquant, Inc. Dba Rhythm Express · cleared 2026-06-22 · product code MNR · Anesthesiology
FDA 510(k) summary for RX-1 Sleep (K253148)
Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.
- Validation studies
- 2
- Cited predicates
- 2
- Performance observations
- 8
- Product code
- MNR
Premarket evidence — what FDA accepted
source quote (p.4)
“RX-1 Sleep is a Software as a Medical Device (SaMD) to aid in the evaluation of sleep-related breathing disorders in adults suspected of having sleep apnea.”
source quote (p.5)
“RX-1 Sleep employs two cloud-based static/locked AI deep learning models for AHI and for sleep/wake that receive inputs from two FDA-cleared devices used in the clinical and home environment: a) the Rhythm Express RX-1 mini Remote Cardiac Monitoring System (RCMS) (K241179), and b) a Viatom pulse oximeter”
source quote (p.5)
“RX-1 Sleep employs two cloud-based static/locked AI deep learning models for AHI and for sleep/wake”
source quote (p.11)
“AAMI TIR 57:2016 Principles for medical device security – Risk management, AAMI TIR 97:2019 Principles for medical device security – Postmarket risk management for device manufacturers, FDA guidance “Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration”, issued February 3, 2026”
Validation studies (2)
Prospective clinical
n=476 patients
endpoints: agreement between RX-1 Sleep predicted AHI and PSG-scored AHI under AASM Rule 1B using Bland-Altman analysis; sensitivity and specificity of RX-1 Sleep for detecting AHI ">= 5" under Rule 1B; sensitivity and specificity of RX-1 Sleep for detecting AHI ">= 15" under Rule 1A and 1B and AHI ">= 5" under Rule 1A; sensitivity and specificity at the severe OSA threshold (AHI ">= 30") under Rule 1A and 1B; sleep/wake classification
standards: FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” issued February 3, 2016, ANSI AMMI ISO 14971:2019 Medical devices – Applications of risk management to medical devices, AAMI TIR 57:2016 Principles for medical device security – Risk management, AAMI TIR 97:2019 Principles for medical device security – Postmarket risk management for device manufacturers, AAMI CR 34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning, ANSI AAMI IEC 62366-1:2015+AMD1:2020 Medical devices Part 1: Application of usability engineering to medical devices including Amendment 1, ISO 15223-1 Fourth edition 2021-07 Medical devices – Symbols to be used with information to be supplied by the manufacturer: Part 1: General requirements, IEC 82304-1 Edition 1.0 2016-10 Health software – Part 1: General requirements for product safety, ANSI AAMI IEC 62304:2006/A1:2106 Medical device software – Software life cycle processes [including Amendment 1 (2016)], AAMI TIR 36:2007 Validation of software for regulated processes, FDA guidance “Content of Premarket Submissions for Device Software Functions" issued June 14, 2023, FDA draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” issued January 7, 2025, FDA guidance “Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration”, issued February 3, 2026, FDA guidance “Off-the-Shelf Software Use in Medical Devices”, issued August 11, 2023
Prospective clinical
n=30 patients
endpoints: posture performance; respiratory effort performance
standards: FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” issued February 3, 2016, ANSI AMMI ISO 14971:2019 Medical devices – Applications of risk management to medical devices, AAMI TIR 57:2016 Principles for medical device security – Risk management, AAMI TIR 97:2019 Principles for medical device security – Postmarket risk management for device manufacturers, AAMI CR 34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning, ANSI AAMI IEC 62366-1:2015+AMD1:2020 Medical devices Part 1: Application of usability engineering to medical devices including Amendment 1, ISO 15223-1 Fourth edition 2021-07 Medical devices – Symbols to be used with information to be supplied by the manufacturer: Part 1: General requirements, IEC 82304-1 Edition 1.0 2016-10 Health software – Part 1: General requirements for product safety, ANSI AAMI IEC 62304:2006/A1:2106 Medical device software – Software life cycle processes [including Amendment 1 (2016)], AAMI TIR 36:2007 Validation of software for regulated processes, FDA guidance “Content of Premarket Submissions for Device Software Functions" issued June 14, 2023, FDA draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” issued January 7, 2025, FDA guidance “Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration”, issued February 3, 2026, FDA guidance “Off-the-Shelf Software Use in Medical Devices”, issued August 11, 2023
Reported performance (8 observations)
source quote (p.13)
“87.80% (83.05%, 91.62%)”
source quote (p.13)
“93.91% (90.00%, 96.63%)”
source quote (p.13)
“91.63% (91.54%, 91.72%)”
source quote (p.13)
“83.34% (83.12%, 83.56%)”
source quote (p.13)
“94.7% (94.6-94.8)”
source quote (p.13)
“94.2% (94.2-94.3)”
source quote (p.13)
“89.1% (88.5-89.8)”
source quote (p.13)
“89.4% (88.7-90.1)”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) 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 510(k) 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.
- 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 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).
- 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.
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