SANSA HSAT

K250882

Huxley Medical · cleared 2025-10-29 · 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 AI/ML components to compute time-series data for clinician review and summary metrics for report output.”
Algorithmcombination 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 addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

standards: IEC 60601-2-47 Ed. 2.0 (2012-02), ANSI AAMI EC12:2000/(R)2015, FDA Guidance Document “Applying Human Factors and Usability Engineering to Medical Devices” Issued February 3, 2016

Retrospective clinical

sample size not stated

endpoints: Aid to Diagnosis of Moderate to Severe OSA (AHI≥15)

Reported performance (6 observations)

sensitivity0.882
source quote (p.9)
“Aid to Diagnosis of Moderate to Severe OSA (AHI≥15): Sensitivity 88.2%, Specificity 87.3%”
specificity0.873
source quote (p.9)
“Aid to Diagnosis of Moderate to Severe OSA (AHI≥15): Sensitivity 88.2%, Specificity 87.3%”
accuracyas written: “ECG Recording Accuracy: Frequency Response”stated without valueCI 0.67 Hz to 40 Hz
source quote (p.9)
“Frequency Response: 0.67 Hz to 40 Hz”
accuracyas written: “ECG Recording Accuracy: Input Impedance”stated without valueCI >10 ΜΩ
source quote (p.9)
“Input Impedance: >10 ΜΩ”
accuracyas written: “ECG Recording Accuracy: Gain Accuracy”stated without valueCI Maximum amplitude error ±10%
source quote (p.9)
“Gain Accuracy: Maximum amplitude error ±10%”
accuracyas written: “Timing Accuracy”stated without valueCI <30 seconds
source quote (p.10)
“Timing Accuracy: <30 seconds”

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
2
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

  • 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/K250882