# K181248: Comarch e-Care Platform

- Pathway: 510(k) (Traditional)
- Applicant: Comarch Healthcare SA
- Decided: Oct 22, 2018 after 165 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K864318 (1987). 73 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103276: Intel Health Guide, Intel Corporation Digital Health Group (2011) Summary page 4.
- K133252: Healthinterlink Beacon, Healthinterlink, LLC (2014) Summary page 4.
- K124000: Medapps 2.0 - Remote Patient Monitoring System, Medapps Inc., Dba Alere Connect (2013) Summary page 4.

## Most influential descendants
- K211822: LifePath Remote Patient Monitoring Platform (2022), 1 descendant of its own
- K252440: EasyTeleMed (2.0.2) (2025), 0 descendants of its own

## Indications for use
The Comarch e-Care Platform is intended to connect with physiological measurement devices (weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, spirometers, glucometers) intended to use at home and send the measurement results to central server. Comarch e-Care Platform serves as Software as a Medical Device and can be used only with FDA cleared measurement devices. Comarch e-Care Platform displays the collected measurements on the Web application and securely stores them in a database server, where the caregiver can view the results, analyze them, leave comments and contact patient if necessary. Caregivers are able to set thresholds individually for each patient. Measurement results sent to e-Care Platform from connected devices are analyzed and if result is beyond the threshold, caregiver gets the notification. The Comarch e-Care Platform is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. The Comarch e-Care Platform is contraindicated for patients requiring direct - medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

Source page: https://510kreport.com/device/K181248
Methodology: https://510kreport.com/methodology