EyeBOX

K201841

Oculogica, Inc. · cleared 2020-09-06 · product code QEA · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“Oculogica's EyeBOX is an eye-tracking device with custom software. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest (chin rest and forehead rest) for the patient, and data processing algorithm.”
Algorithmdata processing algorithm that detects subtle changes in eye movements resulting from concussion
source quote (p.5)
“The data processing algorithm detects subtle changes in eye movements resulting from concussion.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: demonstrate that the spatial precision and step response of the new camera met performance requirements

standards: IEC 60601-1-2:2014 (4TH EDITION) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, Z80.36-2016 - Light Hazard Protection For Ophthalmic Instruments

Standalone

n=84 patients

endpoints: demonstrate that the new camera and analysis could reliably detect blinks and gaze position across the range of gaze positions measured by the device

standards: IEC 60601-1-2:2014 (4TH EDITION) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, Z80.36-2016 - Light Hazard Protection For Ophthalmic Instruments

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
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 (OCULOGICA) — same firm and product code, not necessarily this device · initiated 2019-04-16

    A review of the user manual revealed that two precaution statements were missing.

    recall event 82922 (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/K201841