ClearanceBrief
Panels › Cardiovascular › Product code DPS · Class 2

Electrocardiograph

Regulation 870.2340

8510(k)s in 12 months (580 all time)
4recalls in 12 months (98 all time)
89recalls that name a 510(k)
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Top companies in DPS

Company510(k)sRecalls
Smiths Medical PM, Inc.038
Mortara Instrument, Inc.211
Nihon Kohden America, Inc.210
Edan Instruments, Inc.191
Quinton, Inc.170
WELCH ALLYN, INC/MORTARA016
Hewlett-Packard Co.150
Philips North America014
Burdick Corp.120
Philips Medical Systems92
Decided510(k)Device and applicantCode
Oct 23, 2026K260640Kinetic Software Library
Monebo Technologies, Inc.
DPS
Oct 5, 2026K260005MyoVista wavECG (DG-200-B15-003)
HeartSciences, Inc.
DPS
Sep 29, 2026K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
QT Medical, Inc.
DPS
Sep 25, 2026K254255S-Patch CardioAI
Wellysis Corp., KR
DPS
Jul 2, 2026K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
Edan Instruments, Inc., CN
DPS
Jan 26, 2026K251670MAC 7 Resting ECG Analysis System
Ge Medical Systems Information Technologies, Inc.
DPS
Dec 22, 2025K252361AccurECG Analysis System (v2.0)
Accurkardia, Inc.
DPS
Nov 10, 2025K252474Withings BeamO (SCT02)
Withings, FR
DPS
Aug 6, 2025K250569Cardiologs Holter Platform
Philips France Commercial, FR
DPS
Jul 10, 2025K243252ZBPro Diagnostic
Zbeats, Inc.
DPS
Apr 3, 2025K243305Masimo W1
Masimo Corporation
DPS
Jan 16, 2025K241217CloudHRV™ System (100-01-001)
Inmedix, Inc.
DPS
Dec 17, 2024K241556Cardiac Workstation (5000); Cardiac Workstation (7000)
Philips Medizin Systeme Böblingen GmbH, DE
DPS
Aug 8, 2024K240229Masimo W1
Masimo Corporation
DPS
Jun 20, 2024K232161DeepRhythm Platform
Medicalgorithmics S.A., PL
DPS
Jun 12, 2024K233266MEDIBLU ECG SYSTEM
Mediblu Medical, LLC
DPS
Jun 7, 2024K232816Electrocardiograph, model: ECG301
Shenzhen LE Medical Technology Co., Ltd., CN
DPS
Jun 7, 2024K232035Impala
AliveCor, Inc.
DPS
May 2, 2024K232445CSF-4 (CSF-4)
Cardiacsense, IL
DPS
Apr 5, 2024K232823MCG-S (AM1000)
Amcg Co., Ltd., KR
DPS
Dec 15, 2023K231160Cardio Q50, Cardio Q70
Bionet Co., Ltd., KR
DPS
Nov 21, 2023K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
Trismed Co., Ltd., KR
DPS
Nov 17, 2023K232974EKGenius Smart System
Ekgenius, LLC
DPS
Nov 17, 2023K232512Masimo W1
Masimo Corporation
DPS
Nov 9, 2023K231150Cardio P1
Bionet Co., Ltd., KR
DPS
Aug 23, 2023K230812Withings Scan Monitor 2.0
Withings, FR
DPS
Jul 28, 2023K223670MESI mTablet ECG Diagnostic System, MESI mTablet ECG
Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O., SI
DPS
Jul 28, 2023K222902Electrocardiograph: SE-1200 Pro and SE-1201 Pro
Edan Instruments, Inc., CN
DPS
Jun 23, 2023K223013AccurECG Analysis System
Accurkardia, Inc.
DPS
Jan 6, 2023K221260CSF-3
Cardiacsense, IL
DPS
Dec 2, 2022K221141PageWriter TC35 Cardiograph
Medizin Systeme Boblingen GmbH, DE
DPS
Nov 15, 2022K220535Cardio10
Bionet Co., Ltd., KR
DPS
Oct 18, 2022K221321MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
Ge Medical Systems Information Technologies, Inc.
DPS
Apr 14, 2022K212163Coala Heart Monitor
Coala Life AB, SE
DPS
Apr 7, 2022K212278Electrocardiograph
Edan Instruments, Inc., CN
DPS
Mar 25, 2022K220362LE-12CH
Caf Medical Solutions, Inc.
DPS
Nov 18, 2021K212112Cardiologs Holter Platform
Cardiologs Technologies, FR
DPS
Oct 5, 2021K201456Scan Monitor
Withings SA, FR
DPS
Oct 1, 2021K210140electrocardiograph: SE-1202
Edan Instruments, Inc., CN
DPS
Jun 30, 2021K210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
Philips Medical Systems, CN
DPS
Apr 30, 2021K203786MAC 7 - Resting ECG Analysis System
Ge Medical Systems Information Technologies, Inc.
DPS
Dec 7, 2020K200884B-Secur HeartKey Software Library
B-Secur , Ltd., GB
DPS
Sep 29, 2020K191738PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
Philips Medical Systems, CN
DPS
Jun 11, 2020K193415physIQ Heart Rhythm and Respiration Module
Physiq, Inc.
DPS
Mar 20, 2020K200036AI-ECG Tracker
Shenzhen Carewell Electronics Co., Ltd., CN
DPS
Mar 2, 2020K183425CARDIOVIT AT-102 G2
Schiller AG, CH
DPS
Jan 10, 2020K191692KardioScreen
Imedrix Inc. (Formerly Piitech Inc.)
DPS
Jul 10, 2019K183322physIQ Heart Rhythm and Respiratory Module
Physiq, Inc.
DPS
Mar 15, 2019K182571CardioFlux with Faraday Analytical Cloud
Genetesis, Inc.
DPS
Jan 28, 2019K182093ZOLL ECG Analysis Software
Zoll Manufacturing Corporation
DPS

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