# K211822: LifePath Remote Patient Monitoring Platform

- Pathway: 510(k) (Traditional)
- Applicant: Elastic Care Incorporated
- Decided: Feb 3, 2022 after 234 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: 18 generations back to K864318 (1987). 74 ancestors in all.
1 later device descends from it; 1 cites 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)
- K181248: Comarch e-Care Platform, Comarch Healthcare SA (2018) Summary page 5.

## Most influential descendants
- K252440: EasyTeleMed (2.0.2) (2025), 0 descendants of its own

## Indications for use
The LifePath Remote Patient Monitoring Platform connects with compatible physiological measurement devices (blood pressure meters, pulse oximeters, thermometers, glucometers) to collect vital sign using a Patient App and securely transmit them, unaltered, to LifePath servers. The LifePath Platform is intended to be used at home or in healthcare-related environments such as long-term care facilities or clinics, nursing homes and hospitals. The LifePath Remote Patient Monitoring Platform serves as Software as a Medical Device and can be used only with specific FDA cleared third-party measurement devices. The LifePath Remote Patient Monitoring Platform securely stores the collected information on LifePath servers and make it available for viewing by remotely located clinicians using a Clinician App installed on their smartphones. The clinician can analyze the data, prescribe medications or contact the patient if needed. Clinicians can set thresholds individually for each patient; notifications are sent to the clinician for threshold breaches. The LifePath Platform does not interpret, make diagnoses or serve as a substitute for medical care. It is not intended to provide real time data. The LifePath Platform is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention. It is intended for patients who are willing and capable of managing its use or where its operations can be performed by a caregiver. Clinical judgment and experience of a Clinician are required to check and interpret the information delivered.

Source page: https://510kreport.com/device/K211822
Methodology: https://510kreport.com/methodology