# K042642: Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor)

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Nov 3, 2004 after 37 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011000 (2001). 1 ancestor in all.
52 later devices descend from it; 2 cite it directly.
1 of 54 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011000: Tram 2001 Module, General Electric Medical Systems Information Techn (2001) Summary page 1.

## Most influential descendants
- K071073: Solar 8000 and Transport Pro with Patient Data Module (2007), 51 descendants of its own
- K092027: Carescape Monitor B850 (2009), 38 descendants of its own
- K102239: Carescape Monitor B650 (2010), 32 descendants of its own
- K132533: Carescape Monitor B450 (2013), 14 descendants of its own
- K131223: Carescape Monitor B650 (2013), 13 descendants of its own

## Recalls of this device
- Jun 12, 2012 · Class II · Z-2015-2012: GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use 

## Indications for use
The Aware TM Transport Monitor System (includes Aware POD and Aware Transport Monitor) is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as a hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The Aware POD is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the Aware POD includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Aware Transport Monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Aware POD or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. Both the Aware POD and TRAM acquisition module acquire, process and store information for all aforementioned parameters.

Source page: https://510kreport.com/device/K042642
Methodology: https://510kreport.com/methodology