Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DRG — Predicate Candidate Screening
192 FDA 510(k) clearances under this product code; the 50 most recent screened below.
101 daysmedian FDA review time
296 days90th percentile
192clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261569 | UbiqVue™ 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | 2026-07-09 | 58 | 0 |
| K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026-01-22 | 126 | 0 |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025-10-02 | 59 | 0 |
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025-06-04 | 127 | 0 |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025-05-16 | 154 | 0 |
| K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024-11-12 | 125 | 0 |
| K241101 | BioButton System | Biointellisense, Inc. | 2024-09-26 | 157 | 0 |
| K240251 | ANNE Chest | Sibel Health, Inc. | 2024-06-03 | 125 | 0 |
| K223711 | ANNE One | Sibel Health, Inc. | 2023-08-10 | 241 | 0 |
| K220526 | HD+12, HD+15 | Cardioline S.P.A | 2023-05-15 | 445 | 0 |
| K223073 | Alio | Alio, Inc. | 2023-03-17 | 168 | 0 |
| K222398 | Care Team Portal | Vivify Health, Inc. | 2023-02-06 | 182 | 0 |
| K212957 | BioButton System | Biolntellisense, Inc. | 2022-12-12 | 452 | 1 |
| K221530 | ANNE Pediatric | Sibel, Inc. | 2022-11-22 | 180 | 0 |
| K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022-07-15 | 308 | 0 |
| K213233 | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | 2022-06-23 | 266 | 0 |
| K211365 | Alio Medical Remote Monitoring System | Graftworx, Inc. Dba Alio | 2022-03-24 | 324 | 0 |
| K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022-02-03 | 234 | 0 |
| K211305 | ANNE One | Sibel, Inc. | 2021-09-14 | 138 | 0 |
| K202868 | LifeSignals Multi-Parameter Remote Monitoring Platform | Lifesignals, Inc. | 2021-07-21 | 296 | 0 |
| K200690 | LifeSignals ECG Remote Monitoring Patch Platform | Lifesignals, Inc. | 2020-07-15 | 121 | 0 |
| K191620 | Vitls Platform | Vitls, Inc. | 2020-06-01 | 349 | 0 |
| K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evalu | Vitalconnect, Inc. | 2020-04-20 | 139 | 1 |
| K192875 | Philips Biosensor BX100 | Philips Medical Systems | 2020-04-16 | 191 | 0 |
| K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - | Vitalconnect, Inc. | 2020-02-06 | 129 | 0 |
| K191870 | VV330 Continuous ECG Platform, VivaLNK Adhesive Patch | VivaLNK, Inc. | 2020-01-07 | 179 | 0 |
| K191614 | BioSticker System | Biointellisense, Inc. | 2019-12-18 | 183 | 0 |
| K191331 | Life Sensor Cardiac Monitor | Braveheart Wireless, Inc. | 2019-06-12 | 27 | 0 |
| K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - | Vitalconnect, Inc. | 2019-06-07 | 59 | 0 |
| K183078 | VitalConnect Platform, VitalPatch Biosensor | Vitalconnect, Inc. | 2019-03-07 | 122 | 0 |
| K182297 | Surveyor S2 | Mortara Instrument, Inc. | 2019-01-24 | 153 | 0 |
| K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018-10-22 | 165 | 0 |
| K181196 | Caretaker Remote Display App and Caretaker Software Library | Caretaker Medical, LLC | 2018-10-03 | 149 | 0 |
| K172011 | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeS | Hmicro, Inc. | 2018-06-14 | 346 | 0 |
| K171019 | ScioCardio ECG Transmitter | Synergen Technology Labs, LLC | 2018-05-30 | 420 | 0 |
| K173510 | BioStamp nPoint | Mc10, Inc. | 2018-05-08 | 176 | 0 |
| K172329 | Patient Status Engine | Isansys Lifecare, Ltd. | 2018-04-23 | 264 | 0 |
| K163694 | Rooti Rx ECG Event Recorder, Rooti Link APP Software | Rooti Labs , Ltd. | 2017-11-07 | 314 | 0 |
| K163453 | VitalPatch® VitalConnect Platform | Vitalconnect, Inc. | 2017-11-02 | 328 | 0 |
| K171406 | Optum TeleHealth Application | United Health Group, Inc. | 2017-08-18 | 98 | 0 |
| K171029 | eCareCoordinator | Visicu, Inc. | 2017-07-14 | 99 | 0 |
| K171188 | Ossler Exam Scope | Lr Med, Inc. | 2017-06-23 | 60 | 0 |
| K170973 | VitalWatch Software User Interface | Vitalconnect, Inc. | 2017-06-02 | 60 | 0 |
| K170204 | FFR Link, FFR Signal Processing Module | Boston Scientific Corporation | 2017-03-24 | 60 | 0 |
| K161916 | TelePatch Cardiac Monitor | Medicomp, Inc. | 2016-12-21 | 162 | 0 |
| K153719 | LifeStream Management System, LifeStream Management Suite, L | Honeywell Hommed, LLC | 2016-06-03 | 158 | 0 |
| K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015-12-06 | 125 | 0 |
| K150289 | CARDIOLINE HD+ | Cardioline S.P.A | 2015-08-27 | 203 | 0 |
| K141020 | SURVEYOR S4 MOBILE MONITOR | Mortara Instrument, Inc. | 2014-12-03 | 226 | 0 |
| K141792 | GENESIS TOUCH SYSTEM | Honeywell Hommed | 2014-11-25 | 146 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda