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Cadwell Spike and Seizure Detector

by Cadwell

510(k) K140552

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140552 Date23 Jul 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OMB
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cadwell Spike and Seizure Detector is a software-only product with an algorithm intended to analyze and mark events that may correspond to epileptiform discharge (spike) and electrographic seizure for the purpose of reviewing EEG recordings. This device is designed to assist qualified clinical practitioners in reviewing and interpreting EEG data recorded with a standard montage using the 10/20 electrode placement system.

The device is supplied as software and is intended for use by trained users such as neurologists, clinicians, and registered EEG technicians. It is not a standalone diagnostic tool but requires review, deletion, and interpretation by qualified clinical practitioners who will exercise professional judgment. The device is FDA 510(k) cleared with product code OMB and is classified as a Class II medical device for automatic event detection software for full-montage electroencephalograph.

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