Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

K242737

Empatica S.R.L. · cleared 2025-06-06 · product code MWI · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments.”
AlgorithmMachine Learning-based algorithm for SpO2 Quality Indicator
source quote (p.16)
“The existing SpO2 Quality Indicator (QI) which determines the quality of input photoplethysmography (PPG) data to decide whether a SpO2 output should be exposed to the user will be updated by replacing the rule-based algorithm with a Machine Learning-based algorithm”
Adaptive (vs locked)No
source quote (p.16)
“The modification will be a one-time only change, implemented by replacing the rule-based algorithm with a Machine Learning-based algorithm”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedFDA source did not state this

Validation studies (0)

FDA source did not describe a validation study.

Reported performance (4 observations)

accuracyas written: “Respiratory Rate Accuracy”stated without valueCI 3 brpm Arms
source quote (p.13)
“3 brpm Arms”
accuracyas written: “SpO2 Accuracy”stated without valueCI 3% Arms
source quote (p.13)
“3% Arms”
accuracyas written: “Temperature Accuracy”stated without valueCI ± 0.1°C within 30.0°C - 45.0°C range
source quote (p.14)
“± 0.1°C within 30.0°C - 45.0°C range”
sensitivityas written: “Accelerometer Sensitivity”stated without valueCI 0.488 milli-g per Least Significant Bit
source quote (p.15)
“0.488 milli-g per Least Significant Bit”

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

13
recalls in product code, 24mo
342
MAUDE reports in code, 12mo
+138%
vs code's own 3-yr baseline
5
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code MWI: 342 in the 12 months ending 2026-06, vs a 143.7/12mo average over the prior 3 windows (+138%). 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=MWI

  • recall_reason_pattern

    Software/algorithm-related recall in product code MWI (CHANGE HEALTHCARE CANADA COMPANY, initiated 2025-05-22): "Due to complaints, software update may cause software to unexpectedly shutdown." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97046

  • recall_reason_pattern

    Software/algorithm-related recall in product code MWI (Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom, initiated 2025-03-19): "Medical device software marketed without FDA clearance ." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96616

  • recall_reason_pattern

    Software/algorithm-related recall in product code MWI (GE Medical Systems, LLC, initiated 2024-12-06): "There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96027

  • recall_reason_pattern

    Software/algorithm-related recall in product code MWI (A L I Technologies Ltd, initiated 2024-12-02): "Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s)." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96025

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/K242737