510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152984Substantially Equivalent

Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes

Bio Protech, Inc., Wonju-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152984 is the FDA 510(k) clearance record for Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes, a class II device, cleared for Bio Protech, Inc. on under FDA product code IKT (Electrode, Needle, Diagnostic Electromyograph). FDA records list 17 510(k) clearances for Bio Protech, Inc., from to . As of , FDA records show no recalls naming K152984.

Clearance record

Decision date
Received
(238 days to decision)
Product code
IKT Electrode, Needle, Diagnostic Electromyograph
Regulation
21 CFR 890.1385
Device class
Class II
Review panel
Physical Medicine
Applicant
Bio Protech, Inc. Donghwa Medical Instrument Complex, 151-3,, Wonju-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IKT

Trailing 12 months
1 clearance under product code IKT in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IKT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260