# K011397: Persyst Reveal

- Pathway: 510(k) (Traditional)
- Applicant: Persyst Development Corp.
- Decided: Aug 3, 2001 after 88 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
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stellate Sensa: named in the summary without a submission number

## Most influential descendants
- K092039: Identevent, Version 1.0G (2009), 9 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K213299: Wireless EEG System (2022), 2 descendants of its own
- K254213: Pascall Sensor Unit (PSU1) (2026), 0 descendants of its own

## Indications for use
This software is intended for use by a trained EEG technician or neurologist.

Source page: https://510kreport.com/device/K011397
Methodology: https://510kreport.com/methodology