# K143372: AWARE

- Pathway: 510(k) (Traditional)
- Applicant: Ambient Clinical Analytics
- Decided: Apr 2, 2015 after 128 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K941811 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012349: Metavision Clinical Information System, Imdsoft, Ltd. (2002) Summary page 4.
- K100272: Intellivue Clinical Information Portfolio, Philips Medical Systems (2010) Summary page 4.

## Indications for use
AWARE™ js intended for use in the data collection, presentation, management and storage of patient information, and is used in conjunction with independent patient bedside devices and Hospital Information Systems connected via a network. This device is indicated for use by health care providers when providing patient care in an ICU and Emergency Department healthcare setting. ' AWARE is indicated for use in the clinical care of hospitalized adult and pediatric patient (newborn, infant, child, and adolescent) with or at risk of critical illness. AWARE is not an Electronic Medical Record (EMR) application and AWARE use is not intended to replace electronic data management systems utilized by healthcare institutions such as an EMR, LIMS (Laboratory Information Management System), PACS (Picture Archive Communication), patient medical device monitoring and alarm systems. AWARE is not a medical Alarm System and AWARE use is not intended to replace medical Alarm Systems (including monitors) within a healthcare institution. AWARE provides no auditory alerts nor does it provide monitoring and alerting of life threatening situations such as a ventilator disconnection, asystolia, or arrhythmia. AWARE provides a visual [CU- based status of events reported from the institutions’ source systems to aid in the clinical care decision process.

Source page: https://510kreport.com/device/K143372
Methodology: https://510kreport.com/methodology