510(k) Report

FDA product code · Neurology

Burst Suppression Detection Software For Electroencephalograph

ORTClass II21 CFR 882.1400510(k) required1 decision since 20100 recalls

1 FDA decision since 2010. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of ORT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · ORT

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ORT

Too few ORT 510(k)s in any year since 2007 to give a median.

Recalls per year · ORT

No recall names ORT since 2007.

Adverse event reports per year · ORT

1in 2025

2017: 12025: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code ORT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — ORT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ORT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which ORT devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K092625Wavestate NeuromonitorWavestate, Inc. · 20102generations

What has FDA decided in ORT lately?

  • K092625Wavestate NeuromonitorWavestate, Inc. · 2010

The one ORT decision →

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Other codes under 21 CFR 882.1400.

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