Atlas FDA

DRG

192 FDA 510(k) clearances · Product code

101 daysmedian time to decision
296 days90th percentile
192clearances measured

FDA profile

Official device name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2910
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 107 · 2022: 43 · 2023: 19 · 2024: 26 · 2025: 53 · 2026: 43
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
UbiqVue™ 2AYe Cardiac System (UX2253) (K261569)Lifesignals, Inc.2026-07-09
Perin Health System (PHD80060-2) (K252984)Perin Health Devices, LLC2026-01-22
EasyTeleMed (2.0.2) (K252440)Ingeniars S.R.L.2025-10-02
TeleRehab Aermos Cardiopulmonary Rehabilitation (K250259)The ScottCare Corporation2025-06-04
iBSM (K243837)Iorbit Digital Technologies Private Limited2025-05-16
UbiqVue™ 2A Multi-parameter System (UX2550) (K242018)Lifesignals, Inc.2024-11-12
BioButton System (K241101)Biointellisense, Inc.2024-09-26
ANNE Chest (K240251)Sibel Health, Inc.2024-06-03
ANNE One (K223711)Sibel Health, Inc.2023-08-10
HD+12, HD+15 (K220526)Cardioline S.P.A2023-05-15
Alio (K223073)Alio, Inc.2023-03-17
Care Team Portal (K222398)Vivify Health, Inc.2023-02-06
BioButton System (K212957)Biolntellisense, Inc.2022-12-12
ANNE Pediatric (K221530)Sibel, Inc.2022-11-22
ers2 - ergoline Rehabilitation System (K212883)Ergoline GmbH2022-07-15
EZYPRO ECG Recorder (Model: UG02) (K213233)Sigknow Biomedical Co., Ltd.2022-06-23
Alio Medical Remote Monitoring System (K211365)Graftworx, Inc. Dba Alio2022-03-24
LifePath Remote Patient Monitoring Platform (K211822)Elastic Care Incorporated2022-02-03
ANNE One (K211305)Sibel, Inc.2021-09-14
LifeSignals Multi-Parameter Remote Monitoring Platform (K202868)Lifesignals, Inc.2021-07-21
LifeSignals ECG Remote Monitoring Patch Platform (K200690)Lifesignals, Inc.2020-07-15
Vitls Platform (K191620)Vitls, Inc.2020-06-01
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) (K193343)Vitalconnect, Inc.2020-04-20
Philips Biosensor BX100 (K192875)Philips Medical Systems2020-04-16
VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 (K192757)Vitalconnect, Inc.2020-02-06
VV330 Continuous ECG Platform, VivaLNK Adhesive Patch (K191870)VivaLNK, Inc.2020-01-07
BioSticker System (K191614)Biointellisense, Inc.2019-12-18
Life Sensor Cardiac Monitor (K191331)Braveheart Wireless, Inc.2019-06-12
VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 (K190916)Vitalconnect, Inc.2019-06-07
VitalConnect Platform, VitalPatch Biosensor (K183078)Vitalconnect, Inc.2019-03-07
Surveyor S2 (K182297)Mortara Instrument, Inc.2019-01-24
Comarch e-Care Platform (K181248)Comarch Healthcare SA2018-10-22
Caretaker Remote Display App and Caretaker Software Library (K181196)Caretaker Medical, LLC2018-10-03
LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) (K172011)Hmicro, Inc.2018-06-14
ScioCardio ECG Transmitter (K171019)Synergen Technology Labs, LLC2018-05-30
BioStamp nPoint (K173510)Mc10, Inc.2018-05-08
Patient Status Engine (K172329)Isansys Lifecare, Ltd.2018-04-23
Rooti Rx ECG Event Recorder, Rooti Link APP Software (K163694)Rooti Labs , Ltd.2017-11-07
VitalPatch® VitalConnect Platform (K163453)Vitalconnect, Inc.2017-11-02
Optum TeleHealth Application (K171406)United Health Group, Inc.2017-08-18
eCareCoordinator (K171029)Visicu, Inc.2017-07-14
Ossler Exam Scope (K171188)Lr Med, Inc.2017-06-23
VitalWatch Software User Interface (K170973)Vitalconnect, Inc.2017-06-02
FFR Link, FFR Signal Processing Module (K170204)Boston Scientific Corporation2017-03-24
TelePatch Cardiac Monitor (K161916)Medicomp, Inc.2016-12-21
LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream (K153719)Honeywell Hommed, LLC2016-06-03
Vital Connect Platform, HealthPatch MD, VitalPatch (K152139)Vitalconnect, Inc.2015-12-06
CARDIOLINE HD+ (K150289)Cardioline S.P.A2015-08-27
SURVEYOR S4 MOBILE MONITOR (K141020)Mortara Instrument, Inc.2014-12-03
GENESIS TOUCH SYSTEM (K141792)Honeywell Hommed2014-11-25
LG SMARTHEALTH (K133997)Lg Electronics2014-11-21
ECARE COORDINATOR (ECC) (K141706)Visicu, Inc.2014-09-09
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) (K141167)Vitalconnect, Inc.2014-07-29
FAMILY HEALTHWARE (K132173)Sanitas, Inc.2014-05-30
MYHEALTHPOINT TELEHEALTH MANAGER (K132930)Entra Health Systems2014-04-14
VITALCONNECT PLATFORM BY VITAL CONNECT INC. (K132447)Vitalconnect, Inc.2014-04-03
HEALTHINTERLINK BEACON (K133252)Healthinterlink, LLC2014-03-14
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE (K134004)Cellco Partnership D/B/A Verizon Wireless2014-02-14
PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 (K133587)St. Jude Medical Systems AB2013-12-20
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK (K132803)Medapps Inc., Dba Alere Connect2013-12-12
S HEALTH (K132148)Samsung Electronics Co., Ltd.2013-12-04
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC (K131913)Philips Medizin Systeme Boeblingen GmbH2013-11-26
OPTUM TELEHEALTH APPLICATION (K130971)Optumhealth Care Solutions, Inc.2013-10-23
INTEL-GE CARE INNOVATIONS CONNECT RCM (K130821)Intel-Ge Care Innovations, LLC2013-08-09
VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM (K122458)Cello Partnership D/B/A Verizon Wireless2013-07-30
MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM (K124000)Medapps Inc., Dba Alere Connect2013-07-30
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION (K130360)Constant Care, LLC2013-07-15
AMBIO REMOTE HEALTH MONITORING SYSTEM (K130676)Arrayent Health, LLC D/B/A Ambio Health2013-07-08
PHYSIOLOGICAL DATA PROCESSOR (K122763)Zephyr Technology Corporation2013-06-20
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE (K130290)Intel-Ge Care Innovations, LLC2013-06-04
WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM (K123671)Sanitas, Inc.2013-01-16
REMOTE PRESENCE SYSTEM, MODEL RP-VITA (K123229)Intouch Health, Inc.2012-11-20
MOBILECARE MONITOR (K122333)Aframe Digital, Inc.2012-11-19
TABLET COMMANDER (K122285)Cardiocom, LLC2012-08-14
ICP TRIAGEMANAGER (K122095)Emergo Europe Consulting BV2012-07-26
CONNECTED CARE MOBILE APPLICATION (K120325)Watermark Medical2012-07-18
VIGNET TELEHEALTH MANAGER (K113446)Vignet, Inc.2012-07-16
ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) (K120253)Elcam Medical Acal2012-07-16
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM (K120941)Constant Care, LLC2012-07-03
MIPAL (K120470)Watermark Medical2012-06-08
REMOTE PRESENCE SYSTEM (K120895)Intouch Health, Inc.2012-05-24
3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM (K120704)3M Company2012-05-03
GENESIS TOUCH SYSTEM (K112858)Honeywell Hommed, LLC2012-01-24
TCX-I REMOTE CARE MANAGEMENT SYSTEM (K113493)Bl Healthcare, Inc.2011-12-21
VOCARE MYHEALTH TABLET (K111922)Vocare, Inc.2011-12-02
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM (K112559)Medapps, Inc.2011-12-02
AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER (K111854)St. Jude Medical Systems AB2011-10-21
ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) (K103643)Ascot Technologies, Inc.2011-10-06
TELEMEDCARE HEALTH MONITOR (K103796)Telemedcare Pty, Ltd.2011-08-03
WIRELESS MONITORING SYSTEM (K110809)Carefusion 303, Inc.2011-07-05
WALDO PATIENT MONITOR (K110334)Waldo Health2011-04-12
INTEL HEALTH GUIDE (K103276)Intel Corporation Digital Health Group2011-02-08
NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION (K102106)Nihon Kohden Corp.2010-12-17
M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 (K103214)Lifeline Systems, Inc.2010-12-01
3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM (K101834)3M Company2010-09-03
MODIFICATION TO INTEL HEALTH GUIDE PHS6000 (K101178)Intel Corp.2010-06-29
GENESIS DM MODEL: 6053000A1 (K101242)Honeywell Hommed, LLC2010-06-11
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY (K100427)Taidoc Technology Corporation2010-05-28
POLYTEL(R) APT MODEL: PWA-08-01 (K100524)Polymap Wireless, LLC2010-05-24
ALLY PLATFORM SYSTEM (K093895)Continuity Health Solutions2010-05-20
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