510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920264Substantially Equivalent

Bio-Detek Tracerite EEG Electrode

ZOLL Medical Corporation, Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920264 is the FDA 510(k) clearance record for BIO-DETEK TRACERITE EEG ELECTRODE, a class II device, cleared for Bio-Detek, Inc. on under FDA product code GXY (Electrode, Cutaneous). FDA records list 149 510(k) clearances for ZOLL MEDICAL CORPORATION, from to . As of , FDA records show no recalls naming K920264.

Clearance record

Decision date
Received
(133 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Bio-Detek, Inc. 453 S. Main St.,, Attleboro MA
510(k) summary
Statement
Third party review
No

Clearances, product code GXY

Trailing 12 months
12 clearances under product code GXY in the twelve months to November 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code GXY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20261
April 20262
May 20263
June 20262
July 20261
August 20261
September 20260
October 20261
November 20260