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)
Top companies in DPS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2026 | Midmark Corporation Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062
Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. Open, Classified |
DPS | K103640 |
| Aug 14, 2026 | Philips North America Llc Cardiac Workstation 7000. Product Number: 860441. Open, Classified |
DPS | K241556 |
| Aug 14, 2026 | Philips North America Llc Cardiac Workstation 5000. Product Number: 860439. Open, Classified |
DPS | K241556 |
| Aug 4, 2026 | GE Medical Systems Information Technologies Inc GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph Open, Classified |
DPS | K173830 |
| Oct 22, 2025 | GE Medical Systems, LLC MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4 Open, Classified |
DPS | K173830 |
| Oct 16, 2025 | Philips North America Cardiac Workstation 7000;
Model Number: 860441; Open, Classified |
DPS | K241556 |
| Oct 16, 2025 | Philips North America Cardiac Workstation 5000;
Model Number: 860439; Open, Classified |
DPS | K241556 |
| Apr 14, 2025 | Baxter Healthcare Corporation Welch Allyn CP150 Electrocardiograph: Open, Classified |
DPS | K141582 |
| Dec 23, 2024 | Braemar Manufacturing, LLC Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices. Open, Classified |
DPS | None listed |
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer Open, Classified |
DPS | K152944 |
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph Open, Classified |
DPS | K120865 |
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test Open, Classified |
DPS | K152944 |
| Aug 27, 2024 | Schiller, Ag CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570 Open, Classified |
DPS | K183425 |
| Jul 10, 2024 | Baxter Healthcare Corporation Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardia Open, Classified |
DPS | K141582 |
| Jan 10, 2024 | Baxter Healthcare Corporation XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes:
a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50;
b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-5 Open, Classified |
DPS | None listed |
| Jan 10, 2024 | Baxter Healthcare Corporation XScribe Cardiac Stress Testing System, version 6, with below product names and codes:
a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX;
b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX;
c) XS6/RS6 REVIEW WKSTN KI Open, Classified |
DPS | K152944 |
| Jan 10, 2024 | Baxter Healthcare Corporation Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes:
a) QS6 AM12Q KIT AHA XML / QS6-BXXCS:
b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX:
c) QS6 AM12Q KIT Z200 BCRT Open, Classified |
DPS | K152944 |
| Mar 22, 2023 | Withings Scan Monitor/ScanWatch, model number hwa09
Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2) Open, Classified |
DPS | K201456 |
| Jan 24, 2023 | Baxter Healthcare Corporation Baxter Electrocardiograph, ELI 380 -DCS21 Terminated |
DPS | K142105 |
| Sep 3, 2021 | Welch Allyn Inc Mortara ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers:
ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX,
ELI280-BCB- Open, Classified |
DPS | K122073 |
| Mar 31, 2021 | Welch Allyn Inc Mortara AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. Terminated |
DPS | None listed |
| Mar 31, 2021 | Welch Allyn Inc Mortara Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric po Terminated |
DPS | K173765 |
| Mar 31, 2021 | Welch Allyn Inc Mortara ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. Terminated |
DPS | K142105 |
| Mar 31, 2021 | Welch Allyn Inc Mortara ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. Terminated |
DPS | K122073 |
| Dec 7, 2020 | GE Healthcare, LLC MAC VU360, Electrocardiograph Terminated |
DPS | K173830 |
| Nov 11, 2020 | WELCH ALLYN, INC/MORTARA ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from e Terminated |
DPS | None listed |
| May 19, 2020 | Philips North America, LLC Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designe Terminated |
DPS | K090483 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GR Terminated |
DPS | None listed |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system. Terminated |
DPS | K041607 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquis Terminated |
DPS | K152944 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW.
The Surveyor S12 patient monitor Terminated |
DPS | K173765 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AH Terminated |
DPS | K160685 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LE Terminated |
DPS | K974149 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient Terminated |
DPS | K081800 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10 Terminated |
DPS | K050896 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files. Terminated |
DPS | K093339 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio.
Product Usage: A non-invasive prescr Terminated |
DPS | K092663 K100127 +3 |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | K113144 |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | K113144 |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | K113144 |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | K113144 |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | K113144 |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | K113144 |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | K113144 |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | K113144 |
| Jan 9, 2019 | Philips North America, LLC PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients Open, Classified |
DPS | K113144 |
| Jun 12, 2015 | Mortara Instrument, Inc ELI 380 Electrocardiograph.
The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380
simultaneously acquires data from ea Terminated |
DPS | K142105 |
| Jan 13, 2012 | Del Mar Reynolds Medical, Ltd. Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare faci Terminated |
DPS | K090367 |
| Oct 12, 2011 | Edan Instruments, Inc. ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph
ECG cable is an accessory of the following machines: SE-1 series, SE-3 series Terminated |
DPS | K091513 |
| Jun 17, 2011 | Philips Healthcare Inc. Philips SureSigns VS3 Vital Signs Monitor Models:
VS3 863069, 863070, 453564041251, 453564041261,
VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301
The Sure Terminated |
DPS | K090483 |
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