# K140552: Cadwell Spike and Seizure Detector

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell
- Decided: Jul 23, 2014 after 141 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011397 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011397: Persyst Reveal, Persyst Development Corp. (2001) Summary page 1.

## Indications for use
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 scalp EEG recordings. The marked events are reviewed, deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information. This device does not control the delivery of energy, administration of drugs, or another form of life sustaining function to the patient. It is intended for use in patients who are 18 years or over. This device does not provide any diagnostic conclusion about the patient to the user.

Source page: https://510kreport.com/device/K140552
Methodology: https://510kreport.com/methodology