Alio

K223073

Alio, Inc. · cleared 2023-03-17 · product code DRG · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“Alio is a wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings. The data includes measured hemoglobin (Hgb) and hematocrit (Hct), skin temperature, auscultation sound data, and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the HCP's review. [...] Addition of an artificial intelligence/machine learning (AI/ML) algorithm used in the calculation of the new physiologic parameters”
Algorithmartificial intelligence/machine learning (AI/ML) algorithm
source quote (p.6)
“Addition of an artificial intelligence/machine learning (AI/ML) algorithm used in the calculation of the new physiologic parameters”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“FDA Guidance document, “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.””

Validation studies (2)

Bench

sample size not stated

endpoints: meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate devices

standards: IEC 60601-1 3rd Ed., IEC 60601-1-11:2010, IEC 80601-2-56:2017, IEC 80601-2-61:2017, IEC 62471:2008, IEC 60529:2013, IEC 60086-4:2019, IEC 60601-1-2:2007/2014, FCC Part 15 Radio Frequency Devices, Subpart B - Unintentional Radiators, IEC 62304:2006/A1:2015, FDA Guidance document, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”, IEC 62366-1:2007/2015, FDA Guidance document, “Applying Human Factors and Usability Engineering to Medical Devices", ISO 10993-5:2009, ISO 10993-10:2010, ISO 10093-23:2021

Prospective clinical

n=125 patients

endpoints: establish the accuracy of Alio in the assessment of abnormal potassium levels, and measurement of Hgb and Hct, compared to the standard of care blood results and heart rate

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

1
recalls in product code, 24mo
77
MAUDE reports in code, 12mo
+240%
vs code's own 3-yr baseline
2
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code DRG: 77 in the 12 months ending 2026-06, vs a 22.7/12mo average over the prior 3 windows (+240%). 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=DRG

  • recall_reason_pattern

    Software/algorithm-related recall in product code DRG (Biointellisense Inc. 570 El Camino Real, initiated 2024-07-19): "Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:94943

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 Cardiovascular 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/K223073