Huxley SANSA Home Sleep Apnea Test (1000-00)

K240285

Huxley Medical · cleared 2024-07-15 · product code MNR · Anesthesiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The SANSA HSAT collects multiple physiological signals using a single wearable patch worn on the chest. 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 Al/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 Al/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 Al/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.12)
“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 (4)

Bench

sample size not stated

standards: IEC 60601-2-47, ANSI/AAMI EC12, IEC 62366-1, IEC 60601-1-6, IEC 60601-1-11, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 80601-2-61, ISO 10993-1

Bench

sample size not stated

endpoints: average root mean square error (ARMS) met the required specifications of ≤ 3.5% for reflectance technology

standards: ISO 80601-2-61

Prospective clinical

n=533 patients

endpoints: aid to diagnose moderate to severe SDB

Retrospective clinical

n=340 cases

endpoints: Sensitivity (Sleep); Specificity (Sleep)

Reported performance (4 observations)

sensitivity88.2CI 81.3, 93.2
source quote (p.13)
“Sensitivity of 88.2% (95% CI: 81.3, 93.2)”
specificity87.3CI 82.1, 91.5
source quote (p.13)
“Specificity of 87.3% (95% CI: 82.1, 91.5)”
sensitivityas written: “Sensitivity (Sleep)”95CI 95, 95
source quote (p.13)
“Sensitivity (Sleep): 95% (95% CI: 95, 95)”
specificityas written: “Specificity (Sleep)”63CI 62, 64
source quote (p.13)
“Specificity (Sleep): 63% (95% CI: 62, 64)”

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
1
drift signals on this device
  • 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/K240285