510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983287Substantially Equivalent

Medi-Trace 1610C Combination Defibrillation, Monitoring and Pacing Electrode

Graphic Controls Corp., Buffalo NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983287 is the FDA 510(k) clearance record for MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE, a class III device, cleared for Graphic Controls Corp. on under FDA product code MKJ (Automated External Defibrillators (Non-Wearable)). FDA's definition for product code MKJ reads: "This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an...". FDA records list 55 510(k) clearances for Graphic Controls Corp., from to . As of , FDA records show no recalls naming K983287.

Clearance record

Decision date
Received
(48 days to decision)
Product code
MKJ Automated External Defibrillators (Non-Wearable)
Regulation
21 CFR 870.5310
Device class
Class III
Review panel
Cardiovascular
Applicant
Graphic Controls Corp. 189 Van Rensselaer St., Buffalo NY
510(k) summary
Summary
Third party review
No

Clearances, product code MKJ

Trailing 12 months

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

FDA records show no clearances under product code MKJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MKJ, 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