SANSA HSAT

K244027

Huxley Medical · cleared 2025-01-28 · product code MNR · Anesthesiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Huxley Home Sleep Apnea Test (SANSATM) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The SANSA device contains a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and AI/ML components to compute time-series data for clinician review and summary metrics for report output.”
Algorithmcloud-based algorithm which utilizes a combination of signal processing and AI/ML components
source quote (p.5)
“The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and AI/ML components to compute time-series data for clinician review and summary metrics for report output.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“Cybersecurity Controls Verification to verify the additional cybersecurity controls added to mitigate cybersecurity risks in cellular upload. Cybersecurity Testing in accordance with “Guidance for Industry and Food and Drug Administration Staff: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” issued September 27, 2023.”

Validation studies (1)

Bench

sample size not stated

endpoints: Software Unit & Integration Testing to test firmware, and Software Verification Testing at the system level to verify the end-to-end functionality; Cybersecurity Controls Verification to verify the additional cybersecurity controls added to mitigate cybersecurity risks in cellular upload; Wireless Testing per FCC 47 CFR Part 15 Conducted and Radiated emissions, Part 24 and Part 27 Spurious Emissions, and SAR Testing per FCC 47 CFR Part 2

standards: IEC 62304, Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, FCC 47 CFR Part 15, FCC 47 CFR Part 24, FCC 47 CFR Part 27, FCC 47 CFR Part 2, AAMI TIR 69

Reported performance (2 observations)

sensitivity88.2
source quote (p.7)
“Aid to Diagnosis of Moderate to Severe OSA (AHI≥15): Sensitivity 88.2%, Specificity 87.3%”
specificity87.3
source quote (p.7)
“Aid to Diagnosis of Moderate to Severe OSA (AHI≥15): Sensitivity 88.2%, Specificity 87.3%”

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

0
recalls in product code, 24mo
37
MAUDE reports in code, 12mo
+171%
vs code's own 3-yr baseline
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252497 (decision 2025-12-10) from Huxley Medical for a matching device line ("SANSA HSAT") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252497

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250882 (decision 2025-10-29) from Huxley Medical for a matching device line ("SANSA HSAT") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250882

  • adverse_event_inflection

    MAUDE adverse-event reports for product code MNR: 37 in the 12 months ending 2026-06, vs a 13.7/12mo average over the prior 3 windows (+171%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=MNR

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

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.

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K244027