# K141706: Ecare Coordinator (Ecc)

- Pathway: 510(k) (Traditional)
- Applicant: Visicu, Inc.
- Decided: Sep 9, 2014 after 77 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K864318 (1987). 18 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103214: M3810A Philips Telemonitoring System with Edevice BRIDGED130, Lifeline Systems, Inc. (2010) Summary page 5.
- K041674: The M3810A Philips Telemonitoring System with M3814A SPO2 Unit, Philips Medical Systems (2004) Summary page 5.

## Most influential descendants
- K171029: eCareCoordinator (2017), 1 descendant of its own
- K222398: Care Team Portal (2023), 0 descendants of its own

## Recalls of this device
- Mar 2, 2017 · Class II · Z-1708-2017: eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary syste
- Mar 10, 2016 · Class II · Z-1557-2016: The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later. 

## Indications for use
eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and non-medical information through integrated technologies.

Source page: https://510kreport.com/device/K141706
Methodology: https://510kreport.com/methodology
