# K021325: Modification of Apexpro Telemetry System

- Pathway: 510(k) (Special)
- Applicant: General Electric Medical Systems Information Techn
- Decided: May 7, 2002 after 11 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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: 1 generation back to K000779 (2000). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000779: Apexpro Telemetry System, General Electric Medical Systems Information Techn (2000) Summary page 1.

## Most influential descendants
- K032369: Modification to: Apexpro Telemetry System (2003), 3 descendants of its own
- K033365: Apexpro FH Telemetry System (2003), 2 descendants of its own
- K080251: Apexpro Telemetry Systems (2008), 1 descendant of its own
- K160685: Surveyor S4 Mobile Monitor (2016), 0 descendants of its own

## Recalls of this device
- 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

## 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 and SpO.. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display.

Source page: https://510kreport.com/device/K021325
Methodology: https://510kreport.com/methodology