510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161245Substantially Equivalent

EP-TRACER System

Cardio Tek, BV, Ae Maastricht-Airport Limburg, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161245 is the FDA 510(k) clearance record for EP-TRACER System, a class II device, cleared for Cardio Tek, BV on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 2 510(k) clearances for Cardio Tek, BV, from to . As of , FDA records show one recall naming K161245.

Clearance record

Decision date
Received
(94 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardio Tek, BV Amerikalaan 70, Ae Maastricht-Airport Limburg, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQK

Trailing 12 months
25 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20260