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CardioPulse Prime 3.912422

by Schiller AG

CardioPulse Prime 3.912422 (98310) is a Class II device made by Schiller AG, cleared under FDA 510(k) K183425 on 2 Mar 2020 and listed in FDA GUDID since 5 Nov 2021 (UDI-DI 07613365003772), active (FDA 510(k)), not in commercial distribution (GUDID) as of 12 Nov 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K183425

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613365003772 UDI-DI Date5 Nov 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183425 Date2 Mar 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183425 decided 2 Mar 2020 Active
  • FDA GUDID UDI-DI 07613365003772 listed 5 Nov 2021 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2734-2024 FDA Class II initiated 24 Jul 2024

    Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

Timeline

3 dated events

  1. Cleared FDA 510(k) K183425
  2. Listed FDA GUDID 07613365003772
  3. Recall initiated FDA recalls Z-2734-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CardioPulse Prime
Generic name
Electrocardiograph, professional, multichannel
Model / Ref / Catalog
3.912422, 98310
Primary DI / UDI-DI
07613365003772
510(k) Number
FDA product code
DPS
GMDN term
Electrocardiograph, professional, multichannel
Device class
Class II
Regulation number
870.2340
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Electrocardiograph, professional, multichannel

Cleared under the same submission (K183425)

and 1 more cleared under K183425

Similar devices in this category

Other devices filed under Electrocardiograph, professional, multichannel.

Other devices from Schiller AG

See all devices from Schiller AG →

Properties

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