Embrace

K181861

Empatica Srl · cleared 2018-12-20 · product code POS · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Embrace is a wearable biosensor device that can capture, store, and wirelessly transmit sensor data via Bluetooth to a paired remote device. Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTCS).”
Algorithmon-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTCS)
source quote (p.5)
“Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTCS).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=141 patients · 6 site(s)

endpoints: Positive Percent Agreement (PPA); False Alarm Rate (FAR)

standards: IEC 60601-1:2005+AMD1:2012, IEC 60601-1-2:2014, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-5, ISO 10993-10, IEC 60601-1, IEC 60601-1-2 4th Edition

Reported performance (1 observation)

sensitivity0.9815CI [0.9028; 0.9702]
source quote (p.8)
“On all the 141 patients, the Positive percent agreement (PPA) was found to be 0.9815 (53 out of 54 GTCSs detected), with a 95% confidence interval (CI) of [0.9028; 0.9702], relative to a panel of three readers”

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
0
drift signals on this device

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/K181861