EpiMonitor

K232915

Empatica Srl · cleared 2024-02-15 · product code POS · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“EpiMonitor is a prescription only medical device system composed of a wearable device “EmbracePlus” and paired mobile software application “EpiMonitor” intended as an adjunct to seizure monitoring in adults and children aged 6 and up in a home environment or healthcare facilities.”
AlgorithmEpiAlgo (Version 2.1) - Uses algorithms to analyze EDA and accelerometer data to detect patterns in the data that may be associated with GTC seizures and includes two sensitivity modes "high" for use during periods of rest or sleeping or "low" for use during periods of low-intensity activity, in order to reduce false alarm incidents.
source quote (p.14)
“EpiAlgo (Version 2.1) - Uses algorithms to analyze EDA and accelerometer data to detect patterns in the data that may be associated with GTC seizures and includes two sensitivity modes "high" for use during periods of rest or sleeping or "low" for use during periods of low-intensity activity, in order to reduce false alarm incidents.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.16)
“Cybersecurity activities have been conducted and an assessment made on individual component risks. Documentation has been provided with this application as recommended by the FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". All the EpiMonitor System software components underwent appropriate cybersecurity assessment and testing.”

Validation studies (2)

Bench

sample size not stated

endpoints: equivalence in performance of Embrace and EpiMonitor devices

Retrospective clinical

n=1,444 patients

endpoints: Positive Percentage Agreement (PPA); false alarm rate per 24 hours (FAR)

Reported performance (1 observation)

sensitivity0.8CI 0.64-0.87
source quote (p.18)
“>21 843 3625 2896 0.8 0.77 0.64 0.87”

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
2
MAUDE reports in code, 12mo
+500%
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250515 (decision 2025-06-19) from Empatica Srl for a matching device line ("EpiMonitor") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250515

Recalls attributed to this device

  • Recalling firm matches this device's applicant (EMPATICA SRL Via Enrico Stendhal) — same firm and product code, not necessarily this device · initiated 2023-07-13

    May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

    recall event 93215 (openFDA)

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 Neurology 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/K232915