510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K942461Substantially Equivalent

Neurology Accessories - Mark-Easy 10-20

Optimit USA, Inc., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942461 is the FDA 510(k) clearance record for NEUROLOGY ACCESSORIES - MARK-EASY 10-20, a class II device, cleared for Optimit USA, Inc. on under FDA product code GXY (Electrode, Cutaneous). FDA records list one 510(k) clearance for Optimit USA, Inc. As of , FDA records show no recalls naming K942461.

Clearance record

Decision date
Received
(148 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Optimit USA, Inc. 8522 E. Helen Pl., Tucson AZ
510(k) summary
Summary
Third party review
No

Clearances, product code GXY

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