# K131585: Intel-GE Care Innovations Quietcare

- Pathway: 510(k) (Traditional)
- Applicant: Intel-Ge Care Innovations, LLC
- Decided: Oct 8, 2013 after 130 days
- Product code: KMI (Monitor, Bed Patient)
- Device class: 1
- Regulation: 21 CFR 880.2400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925529 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090138: Mobilecare Monitor, Model 2100, Aframe Digital, Inc. (2009) Summary page 1.
- K101109: Vivatrak, Wireless Medcare, LLC (2010) Summary page 1.

## Indications for use
QuietCare-Networked is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked recognizes and monitors certain patterns of activity including but not limited to bathroom and bedroom activity, residence entry/exit, and interaction with food and medication storage. Caregivers are provided with information and notification about the occurrence of, and changes in, these monitored activity patterns and environmental conditions. Noteworthy occurrences and changes are communicated to caregivers through direct notification (pager, voice alert, email) as well as a secure Internet website. Data from QuietCare-Networked should not be relied on as medical advice or clinical diagnosis. Caregivers should always rely on licensed medical professionals in making all health decisions and should use the information provided by QuietCare as a resource in that process. Caregivers should not rely solely on the use of QuietCare-Networked for care management of clients/residents. Caregivers should use standard care practices established within their care organization to ensure the safety and wellness of senior clients/residents.

Source page: https://510kreport.com/device/K131585
Methodology: https://510kreport.com/methodology