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Ep-Tracer 60SYS01

by CardioTek B.V.

Ep-Tracer 60SYS01 is a Class II device made by CardioTek B.V., cleared under FDA 510(k) K183266 on 1 Mar 2019 and listed in FDA GUDID since 10 Dec 2024 (UDI-DI 04260441452615), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K183266

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260441452615 UDI-DI Date10 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK183266 Date1 Mar 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183266 decided 1 Mar 2019 Active
  • FDA GUDID UDI-DI 04260441452615 listed 10 Dec 2024 Listed

Recalls

1 recall · FDA

    • Completed Z-1283-2022 FDA Class II initiated 25 Apr 2022

    Device did not pass electrical safety testing for adequate insulation.

Timeline

3 dated events

  1. Cleared FDA 510(k) K183266
  2. Recall initiated FDA recalls Z-1283-2022
  3. Listed FDA GUDID 04260441452615

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ep-Tracer
Generic name
Cardiac electrophysiology analysis system
Model / reference
60SYS01
Primary DI / UDI-DI
04260441452615
510(k) Number
FDA product code
DQK
GMDN term
Cardiac electrophysiology analysis system
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac electrophysiology analysis system

Cleared under the same submission (K183266)

and 3 more cleared under K183266

Similar devices

Other devices filed under FDA product code DQK (Computer, Diagnostic, Programmable).

Other devices from CardioTek B.V.

See all devices from CardioTek B.V. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)