510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253581Substantially Equivalent

Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)

Technomed Europe, Kerkrade, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253581 is the FDA 510(k) clearance record for Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005), a class II device, cleared for Technomed Europe on under FDA product code IKT (Electrode, Needle, Diagnostic Electromyograph). FDA records list 13 510(k) clearances for Technomed Europe, from to . As of , FDA records show no recalls naming K253581.

Clearance record

Decision date
Received
(118 days to decision)
Product code
IKT Electrode, Needle, Diagnostic Electromyograph
Regulation
21 CFR 890.1385
Device class
Class II
Review panel
Physical Medicine
Applicant
Technomed Europe Wiebachstraat 25a, Kerkrade, NL
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