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D4PCIUGCII

by Medtronic, Inc.

D4PCIUGCII is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K024278 on 29 May 2003 and listed in FDA GUDID since 1 Apr 2016 (UDI-DI 00613994371751), active as of 23 Oct 2026. 2 FDA recalls are 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

2 closed

Documents

510(k) K024278

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 Number00613994371751 UDI-DI Date1 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK024278 Date29 May 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K024278 decided 29 May 2003 Active
  • FDA GUDID UDI-DI 00613994371751 listed 1 Apr 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0081-2008 FDA Unclassified (pre-2012) initiated 27 Aug 2007

    An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting

    • Terminated Z-0911-06 FDA Unclassified (pre-2012) initiated 2 Feb 2006

    The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.

Timeline

4 dated events

  1. Cleared FDA 510(k) K024278
  2. Recall initiated FDA recalls Z-0911-06
  3. Recall initiated FDA recalls Z-0081-2008
  4. Listed FDA GUDID 00613994371751

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Patient health record information system application software
Model / reference
D4PCIUGCII
Primary DI / UDI-DI
00613994371751
510(k) Number
FDA product code
KRE, DPS, DXH
GMDN term
Patient health record information system application software
Device class
Class II
Regulation number
870.3640, 870.2340, 870.2920
GUDID distribution status
In Commercial Distribution

Related devices

Category: Patient health record information system application software

Cleared under the same submission (K024278)

and 7 more cleared under K024278

Similar devices in this category

Other devices filed under Patient health record information system application software.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)