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Epiphany Cardio Server 5.1.0

by Epiphany Healthcare Data Management, LLC

Epiphany Cardio Server 5.1.0 is a Class II device made by Epiphany Healthcare Data Management, LLC, cleared under FDA 510(k) K052883 on 1 Nov 2005 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00860991000300), active as of 22 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

1 ongoing

This device is named in the recall

Documents

510(k) K052883

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860991000300 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052883 Date1 Nov 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052883 decided 1 Nov 2005 Active
  • FDA GUDID UDI-DI 00860991000300 listed 9 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2647-2023 FDA Class II initiated 10 Aug 2023

    Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.

Timeline

3 dated events

  1. Cleared FDA 510(k) K052883
  2. Listed FDA GUDID 00860991000300
  3. Recall initiated FDA recalls Z-2647-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Epiphany Cardio Server
Generic name
Cardiology information system application software
Model / reference
5.1.0
Primary DI / UDI-DI
00860991000300
510(k) Number
FDA product code
DQK
GMDN term
Cardiology information system application software
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiology information system application software

Cleared under the same submission (K052883)

and 6 more cleared under K052883

Similar devices

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

Other devices from Epiphany Healthcare Data Management, LLC

See all devices from Epiphany Healthcare Data Management, LLC →

Properties

  • Manufacturing date
Other properties (14, all answered No)