510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K092625Substantially Equivalent

Wavestate Neuromonitor

Wavestate, Inc., Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092625 is the FDA 510(k) clearance record for WAVESTATE NEUROMONITOR, a class II device, cleared for Wavestate, Inc. on under FDA product code ORT (Burst Suppression Detection Software For Electroencephalograph). FDA's definition for product code ORT 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...". FDA records list one 510(k) clearance for Wavestate, Inc. As of , FDA records show no recalls naming K092625.

Clearance record

Decision date
Received
(306 days to decision)
Product code
ORT Burst Suppression Detection Software For Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Wavestate, Inc. 1468 Harwell Ave., Crofton MD
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code ORT

Trailing 12 months

FDA records hold no clearances under product code ORT in the trailing twelve months.

FDA records show no clearances under product code ORT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ORT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260