ORTClass II

Burst Suppression Detection Software For Electroencephalograph

21 CFR 882.1400 / Neurology

ORT is the FDA product code for Burst Suppression Detection Software For Electroencephalograph, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2010-06-29, and no recalls.

Classification record

Product code: ORT
Device name: Burst Suppression Detection Software For Electroencephalograph
FDA definition: Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user.
Regulation: 21 CFR 882.1400
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code ORT

By decision year

1 clearance under product code ORT with a decision year between 2010 and 2010, 2010 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code ORT by decision year
Year	Clearances
2010	1

Applicants with the most clearances

Product code ORT

Applicants holding the most 510(k) clearances under product code ORT
Applicant	Clearances
Wavestate, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order

Recent clearances

Product code ORT

K092625Class IIWavestate NeuromonitorWavestate, Inc. / cleared 2010-06-29

Recent recalls

Product code ORT

FDA records show no recalls under product code ORT.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)