FDA Product Code
FDA Product Code DRG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2910
510(k) Clearances — 192 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261569 | UbiqVue 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | 2026-07-09 | Traditional | PDF ↗ |
| K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026-01-22 | Traditional | PDF ↗ |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025-10-02 | Traditional | PDF ↗ |
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025-06-04 | Traditional | PDF ↗ |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025-05-16 | Traditional | PDF ↗ |
| K242018 | UbiqVue 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024-11-12 | Traditional | PDF ↗ |
| K241101 | BioButton System | Biointellisense, Inc. | 2024-09-26 | Traditional | PDF ↗ |
| K240251 | ANNE Chest | Sibel Health, Inc. | 2024-06-03 | Traditional | PDF ↗ |
| K223711 | ANNE One | Sibel Health, Inc. | 2023-08-10 | Traditional | PDF ↗ |
| K220526 | HD+12, HD+15 | Cardioline S.P.A | 2023-05-15 | Traditional | PDF ↗ |
| K223073 | Alio | Alio, Inc. | 2023-03-17 | Traditional | PDF ↗ |
| K222398 | Care Team Portal | Vivify Health, Inc. | 2023-02-06 | Traditional | PDF ↗ |
| K212957 | BioButton System | Biolntellisense, Inc. | 2022-12-12 | Traditional | PDF ↗ |
| K221530 | ANNE Pediatric | Sibel, Inc. | 2022-11-22 | Traditional | PDF ↗ |
| K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022-07-15 | Traditional | PDF ↗ |
| K213233 | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | 2022-06-23 | Traditional | PDF ↗ |
| K211365 | Alio Medical Remote Monitoring System | Graftworx, Inc. Dba Alio | 2022-03-24 | Traditional | PDF ↗ |
| K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022-02-03 | Traditional | PDF ↗ |
| K211305 | ANNE One | Sibel, Inc. | 2021-09-14 | Traditional | PDF ↗ |
| K202868 | LifeSignals Multi-Parameter Remote Monitoring Platform | Lifesignals, Inc. | 2021-07-21 | Traditional | PDF ↗ |
| K200690 | LifeSignals ECG Remote Monitoring Patch Platform | Lifesignals, Inc. | 2020-07-15 | Traditional | PDF ↗ |
| K191620 | Vitls Platform | Vitls, Inc. | 2020-06-01 | Traditional | PDF ↗ |
| K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) | Vitalconnect, Inc. | 2020-04-20 | Traditional | PDF ↗ |
| K192875 | Philips Biosensor BX100 | Philips Medical Systems | 2020-04-16 | Traditional | PDF ↗ |
| K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20 | Vitalconnect, Inc. | 2020-02-06 | Traditional | PDF ↗ |
| K191870 | VV330 Continuous ECG Platform, VivaLNK Adhesive Patch | VivaLNK, Inc. | 2020-01-07 | Traditional | PDF ↗ |
| K191614 | BioSticker System | Biointellisense, Inc. | 2019-12-18 | Traditional | PDF ↗ |
| K191331 | Life Sensor Cardiac Monitor | Braveheart Wireless, Inc. | 2019-06-12 | Traditional | PDF ↗ |
| K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 | Vitalconnect, Inc. | 2019-06-07 | Traditional | PDF ↗ |
| K183078 | VitalConnect Platform, VitalPatch Biosensor | Vitalconnect, Inc. | 2019-03-07 | Traditional | PDF ↗ |
| K182297 | Surveyor S2 | Mortara Instrument, Inc. | 2019-01-24 | Traditional | PDF ↗ |
| K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018-10-22 | Traditional | PDF ↗ |
| K181196 | Caretaker Remote Display App and Caretaker Software Library | Caretaker Medical, LLC | 2018-10-03 | Traditional | PDF ↗ |
| K172011 | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) | Hmicro, Inc. | 2018-06-14 | Traditional | PDF ↗ |
| K171019 | ScioCardio ECG Transmitter | Synergen Technology Labs, LLC | 2018-05-30 | Traditional | PDF ↗ |
| K173510 | BioStamp nPoint | Mc10, Inc. | 2018-05-08 | Traditional | PDF ↗ |
| K172329 | Patient Status Engine | Isansys Lifecare, Ltd. | 2018-04-23 | Traditional | PDF ↗ |
| K163694 | Rooti Rx ECG Event Recorder, Rooti Link APP Software | Rooti Labs , Ltd. | 2017-11-07 | Traditional | PDF ↗ |
| K163453 | VitalPatch® VitalConnect Platform | Vitalconnect, Inc. | 2017-11-02 | Traditional | PDF ↗ |
| K171406 | Optum TeleHealth Application | United Health Group, Inc. | 2017-08-18 | Special | PDF ↗ |
| K171029 | eCareCoordinator | Visicu, Inc. | 2017-07-14 | Traditional | PDF ↗ |
| K171188 | Ossler Exam Scope | Lr Med, Inc. | 2017-06-23 | Traditional | PDF ↗ |
| K170973 | VitalWatch Software User Interface | Vitalconnect, Inc. | 2017-06-02 | Traditional | PDF ↗ |
| K170204 | FFR Link, FFR Signal Processing Module | Boston Scientific Corporation | 2017-03-24 | Traditional | PDF ↗ |
| K161916 | TelePatch Cardiac Monitor | Medicomp, Inc. | 2016-12-21 | Traditional | PDF ↗ |
| K153719 | LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream | Honeywell Hommed, LLC | 2016-06-03 | Traditional | PDF ↗ |
| K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015-12-06 | Traditional | PDF ↗ |
| K150289 | CARDIOLINE HD+ | Cardioline S.P.A | 2015-08-27 | Traditional | PDF ↗ |
| K141020 | SURVEYOR S4 MOBILE MONITOR | Mortara Instrument, Inc. | 2014-12-03 | Traditional | PDF ↗ |
| K141792 | GENESIS TOUCH SYSTEM | Honeywell Hommed | 2014-11-25 | Traditional | PDF ↗ |
| K133997 | LG SMARTHEALTH | Lg Electronics | 2014-11-21 | Traditional | PDF ↗ |
| K141706 | ECARE COORDINATOR (ECC) | Visicu, Inc. | 2014-09-09 | Traditional | PDF ↗ |
| K141167 | VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) | Vitalconnect, Inc. | 2014-07-29 | Traditional | PDF ↗ |
| K132173 | FAMILY HEALTHWARE | Sanitas, Inc. | 2014-05-30 | Traditional | PDF ↗ |
| K132930 | MYHEALTHPOINT TELEHEALTH MANAGER | Entra Health Systems | 2014-04-14 | Traditional | PDF ↗ |
| K132447 | VITALCONNECT PLATFORM BY VITAL CONNECT INC. | Vitalconnect, Inc. | 2014-04-03 | Traditional | PDF ↗ |
| K133252 | HEALTHINTERLINK BEACON | Healthinterlink, LLC | 2014-03-14 | Traditional | PDF ↗ |
| K134004 | VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE | Cellco Partnership D/B/A Verizon Wireless | 2014-02-14 | Traditional | PDF ↗ |
| K133587 | PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 | St. Jude Medical Systems AB | 2013-12-20 | Special | PDF ↗ |
| K132803 | MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK | Medapps Inc., Dba Alere Connect | 2013-12-12 | Special | PDF ↗ |
| K132148 | S HEALTH | Samsung Electronics Co., Ltd. | 2013-12-04 | Traditional | PDF ↗ |
| K131913 | INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC | Philips Medizin Systeme Boeblingen GmbH | 2013-11-26 | Abbreviated | PDF ↗ |
| K130971 | OPTUM TELEHEALTH APPLICATION | Optumhealth Care Solutions, Inc. | 2013-10-23 | Traditional | PDF ↗ |
| K130821 | INTEL-GE CARE INNOVATIONS CONNECT RCM | Intel-Ge Care Innovations, LLC | 2013-08-09 | Abbreviated | PDF ↗ |
| K124000 | MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM | Medapps Inc., Dba Alere Connect | 2013-07-30 | Traditional | PDF ↗ |
| K122458 | VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM | Cello Partnership D/B/A Verizon Wireless | 2013-07-30 | Traditional | PDF ↗ |
| K130360 | CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION | Constant Care, LLC | 2013-07-15 | Traditional | PDF ↗ |
| K130676 | AMBIO REMOTE HEALTH MONITORING SYSTEM | Arrayent Health, LLC D/B/A Ambio Health | 2013-07-08 | Traditional | PDF ↗ |
| K122763 | PHYSIOLOGICAL DATA PROCESSOR | Zephyr Technology Corporation | 2013-06-20 | Traditional | PDF ↗ |
| K130290 | MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE | Intel-Ge Care Innovations, LLC | 2013-06-04 | Traditional | PDF ↗ |
| K123671 | WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM | Sanitas, Inc. | 2013-01-16 | Traditional | PDF ↗ |
| K123229 | REMOTE PRESENCE SYSTEM, MODEL RP-VITA | Intouch Health, Inc. | 2012-11-20 | Traditional | PDF ↗ |
| K122333 | MOBILECARE MONITOR | Aframe Digital, Inc. | 2012-11-19 | Traditional | PDF ↗ |
| K122285 | TABLET COMMANDER | Cardiocom, LLC | 2012-08-14 | Traditional | PDF ↗ |
| K122095 | ICP TRIAGEMANAGER | Emergo Europe Consulting BV | 2012-07-26 | Traditional | PDF ↗ |
| K120325 | CONNECTED CARE MOBILE APPLICATION | Watermark Medical | 2012-07-18 | Traditional | PDF ↗ |
| K113446 | VIGNET TELEHEALTH MANAGER | Vignet, Inc. | 2012-07-16 | Traditional | PDF ↗ |
| K120253 | ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) | Elcam Medical Acal | 2012-07-16 | Traditional | PDF ↗ |
| K120941 | CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM | Constant Care, LLC | 2012-07-03 | Traditional | PDF ↗ |
| K120470 | MIPAL | Watermark Medical | 2012-06-08 | Traditional | PDF ↗ |
| K120895 | REMOTE PRESENCE SYSTEM | Intouch Health, Inc. | 2012-05-24 | Traditional | PDF ↗ |
| K120704 | 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM | 3M Company | 2012-05-03 | Traditional | PDF ↗ |
| K112858 | GENESIS TOUCH SYSTEM | Honeywell Hommed, LLC | 2012-01-24 | Traditional | PDF ↗ |
| K113493 | TCX-I REMOTE CARE MANAGEMENT SYSTEM | Bl Healthcare, Inc. | 2011-12-21 | Special | PDF ↗ |
| K112559 | MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM | Medapps, Inc. | 2011-12-02 | Special | PDF ↗ |
| K111922 | VOCARE MYHEALTH TABLET | Vocare, Inc. | 2011-12-02 | Traditional | PDF ↗ |
| K111854 | AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER | St. Jude Medical Systems AB | 2011-10-21 | Traditional | PDF ↗ |
| K103643 | ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) | Ascot Technologies, Inc. | 2011-10-06 | Abbreviated | PDF ↗ |
| K103796 | TELEMEDCARE HEALTH MONITOR | Telemedcare Pty, Ltd. | 2011-08-03 | Traditional | PDF ↗ |
| K110809 | WIRELESS MONITORING SYSTEM | Carefusion 303, Inc. | 2011-07-05 | Traditional | PDF ↗ |
| K110334 | WALDO PATIENT MONITOR | Waldo Health | 2011-04-12 | Traditional | PDF ↗ |
| K103276 | INTEL HEALTH GUIDE | Intel Corporation Digital Health Group | 2011-02-08 | Abbreviated | PDF ↗ |
| K102106 | NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION | Nihon Kohden Corp. | 2010-12-17 | Traditional | PDF ↗ |
| K103214 | M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 | Lifeline Systems, Inc. | 2010-12-01 | Special | PDF ↗ |
| K101834 | 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM | 3M Company | 2010-09-03 | Traditional | PDF ↗ |
| K101178 | MODIFICATION TO INTEL HEALTH GUIDE PHS6000 | Intel Corp. | 2010-06-29 | Special | PDF ↗ |
| K101242 | GENESIS DM MODEL: 6053000A1 | Honeywell Hommed, LLC | 2010-06-11 | Special | PDF ↗ |
| K100427 | FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY | Taidoc Technology Corporation | 2010-05-28 | Traditional | PDF ↗ |
| K100524 | POLYTEL(R) APT MODEL: PWA-08-01 | Polymap Wireless, LLC | 2010-05-24 | Abbreviated | PDF ↗ |
| K093895 | ALLY PLATFORM SYSTEM | Continuity Health Solutions | 2010-05-20 | Traditional | PDF ↗ |
Product code DRG · Class II · Cardiovascular. Data: openFDA.