510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K834583Substantially Equivalent

Clear Leads-Radiotransparent Wires

Quinton, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834583 is the FDA 510(k) clearance record for CLEAR LEADS-RADIOTRANSPARENT WIRES, a class II device, cleared for Quinton, Inc. on under FDA product code IKD (Cable, Electrode). FDA records list 164 510(k) clearances for Quinton, Inc., from to . As of , FDA records show no recalls naming K834583.

Clearance record

Decision date
Received
(32 days to decision)
Product code
IKD Cable, Electrode
Regulation
21 CFR 890.1175
Device class
Class II
Review panel
Physical Medicine
Applicant
Quinton, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IKD

Trailing 12 months

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

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