# K080251: Apexpro Telemetry Systems

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jun 20, 2008 after 141 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000779 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032369: Modification to: Apexpro Telemetry System, Ge Medical Systems Information Technologies (2003) Summary page 1.
- K033365: Apexpro FH Telemetry System, Ge Medical Systems Information Technologies (2003) Summary page 1.
- K980299: Apex Oximeter, Marquette Medical Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- K160685: Surveyor S4 Mobile Monitor (2016), 0 descendants of its own

## Recalls of this device
- Apr 24, 2026 · Class II · Z-2242-2026: GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent N
- Nov 12, 2019 · Class II · Z-0725-2020: When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) v
- Aug 30, 2019 · Class II · Z-0175-2020: May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditio
- Jan 28, 2011 · Not classified · Z-1522-2011: GE Healthcare has become aware of a potential for loss of patient monitoring when ApexPro Telemetry System is used in conjunction with a mirrored view CARESCAPE CIC Pro in combination monitoring mode 

## Indications for use
The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered. The physiological parameters monitored include ECG, non-invasive blood pressure, non-invasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display.

Source page: https://510kreport.com/device/K080251
Methodology: https://510kreport.com/methodology