Panels › Cardiovascular › Product code DRG · Class 2
Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation 870.2910
2510(k)s in 12 months (192 all time)
1recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in DRG
| Company | 510(k)s | Recalls |
|---|---|---|
| Vitalconnect, Inc. | 9 | 1 |
| Honeywell Hommed | 6 | 0 |
| Nihon Kohden America, Inc. | 5 | 1 |
| American Telecare, Inc. | 5 | 0 |
| General Devices | 5 | 0 |
| Bl Healthcare, Inc. | 4 | 0 |
| Health Hero Network, Inc. | 4 | 0 |
| Lifesignals, Inc. | 4 | 0 |
| Philips Medical Systems | 4 | 0 |
| Biointellisense, Inc. | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 9, 2026 | K261569 | UbiqVue 2AYe Cardiac System (UX2253) Lifesignals, Inc. | DRG |
| Jan 22, 2026 | K252984 | Perin Health System (PHD80060-2) Perin Health Devices, LLC | DRG |
| Oct 2, 2025 | K252440 | EasyTeleMed (2.0.2) Ingeniars S.R.L., IT | DRG |
| Jun 4, 2025 | K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation The ScottCare Corporation | DRG |
| May 16, 2025 | K243837 | iBSM Iorbit Digital Technologies Private Limited, IN | DRG |
| Nov 12, 2024 | K242018 | UbiqVue 2A Multi-parameter System (UX2550) Lifesignals, Inc. | DRG |
| Sep 26, 2024 | K241101 | BioButton System Biointellisense, Inc. | DRG |
| Jun 3, 2024 | K240251 | ANNE Chest Sibel Health, Inc. | DRG |
| Aug 10, 2023 | K223711 | ANNE One Sibel Health, Inc. | DRG |
| May 15, 2023 | K220526 | HD+12, HD+15 Cardioline S.P.A, IT | DRG |
| Mar 17, 2023 | K223073 | Alio Alio, Inc. | DRG |
| Feb 6, 2023 | K222398 | Care Team Portal Vivify Health, Inc. | DRG |
| Dec 12, 2022 | K212957 | BioButton System Biolntellisense, Inc. | DRG |
| Nov 22, 2022 | K221530 | ANNE Pediatric Sibel, Inc. | DRG |
| Jul 15, 2022 | K212883 | ers2 - ergoline Rehabilitation System Ergoline GmbH, DE | DRG |
| Jun 23, 2022 | K213233 | EZYPRO ECG Recorder (Model: UG02) Sigknow Biomedical Co., Ltd., TW | DRG |
| Mar 24, 2022 | K211365 | Alio Medical Remote Monitoring System Graftworx, Inc. Dba Alio | DRG |
| Feb 3, 2022 | K211822 | LifePath Remote Patient Monitoring Platform Elastic Care Incorporated, CA | DRG |
| Sep 14, 2021 | K211305 | ANNE One Sibel, Inc. | DRG |
| Jul 21, 2021 | K202868 | LifeSignals Multi-Parameter Remote Monitoring Platform Lifesignals, Inc. | DRG |
| Jul 15, 2020 | K200690 | LifeSignals ECG Remote Monitoring Patch Platform Lifesignals, Inc. | DRG |
| Jun 1, 2020 | K191620 | Vitls Platform Vitls, Inc. | DRG |
| Apr 20, 2020 | K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) Vitalconnect, Inc. | DRG |
| Apr 16, 2020 | K192875 | Philips Biosensor BX100 Philips Medical Systems | DRG |
| Feb 6, 2020 | K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D B Vitalconnect, Inc. | DRG |
| Jan 7, 2020 | K191870 | VV330 Continuous ECG Platform, VivaLNK Adhesive Patch VivaLNK, Inc. | DRG |
| Dec 18, 2019 | K191614 | BioSticker System Biointellisense, Inc. | DRG |
| Jun 12, 2019 | K191331 | Life Sensor Cardiac Monitor Braveheart Wireless, Inc. | DRG |
| Jun 7, 2019 | K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 Vitalconnect, Inc. | DRG |
| Mar 7, 2019 | K183078 | VitalConnect Platform, VitalPatch Biosensor Vitalconnect, Inc. | DRG |
| Jan 24, 2019 | K182297 | Surveyor S2 Mortara Instrument, Inc. | DRG |
| Oct 22, 2018 | K181248 | Comarch e-Care Platform Comarch Healthcare SA, PL | DRG |
| Oct 3, 2018 | K181196 | Caretaker Remote Display App and Caretaker Software Library Caretaker Medical, LLC | DRG |
| Jun 14, 2018 | K172011 | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) Hmicro, Inc. | DRG |
| May 30, 2018 | K171019 | ScioCardio ECG Transmitter Synergen Technology Labs, LLC | DRG |
| May 8, 2018 | K173510 | BioStamp nPoint Mc10, Inc. | DRG |
| Apr 23, 2018 | K172329 | Patient Status Engine Isansys Lifecare, Ltd., GB | DRG |
| Nov 7, 2017 | K163694 | Rooti Rx ECG Event Recorder, Rooti Link APP Software Rooti Labs , Ltd., TW | DRG |
| Nov 2, 2017 | K163453 | VitalPatch® VitalConnect Platform Vitalconnect, Inc. | DRG |
| Aug 18, 2017 | K171406 | Optum TeleHealth Application United Health Group, Inc. | DRG |
| Jul 14, 2017 | K171029 | eCareCoordinator Visicu, Inc. | DRG |
| Jun 23, 2017 | K171188 | Ossler Exam Scope Lr Med, Inc. | DRG |
| Jun 2, 2017 | K170973 | VitalWatch Software User Interface Vitalconnect, Inc. | DRG |
| Mar 24, 2017 | K170204 | FFR Link, FFR Signal Processing Module Boston Scientific Corporation | DRG |
| Dec 21, 2016 | K161916 | TelePatch Cardiac Monitor Medicomp, Inc. | DRG |
| Jun 3, 2016 | K153719 | LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream We Honeywell Hommed, LLC | DRG |
| Dec 6, 2015 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch Vitalconnect, Inc. | DRG |
| Aug 27, 2015 | K150289 | CARDIOLINE HD+ Cardioline S.P.A | DRG |
| Dec 3, 2014 | K141020 | SURVEYOR S4 MOBILE MONITOR Mortara Instrument, Inc. | DRG |
| Nov 25, 2014 | K141792 | GENESIS TOUCH SYSTEM Honeywell Hommed | DRG |
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