510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862655Substantially Equivalent

Signa II Resting ECG Electrode

Kone Instruments, Inc., Milton WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862655 is the FDA 510(k) clearance record for SIGNA II RESTING ECG ELECTRODE, a class II device, cleared for Kone Instruments, Inc. on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 12 510(k) clearances for Kone Instruments, Inc., from to . As of , FDA records show no recalls naming K862655.

Clearance record

Decision date
Received
(23 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Kone Instruments, Inc. Burdick Division, Milton WI
Third party review
No

Clearances, product code DRX

Trailing 12 months

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

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