# K000779: Apexpro Telemetry System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: May 18, 2000 after 69 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021325: Modification of Apexpro Telemetry System (2002), 4 descendants of its own
- K081800: T12S Telemetry Transmitter (2008), 3 descendants of its own
- K032369: Modification to: Apexpro Telemetry System (2003), 3 descendants of its own
- K141020: Surveyor S4 Mobile Monitor (2014), 2 descendants of its own
- K033365: Apexpro FH Telemetry System (2003), 2 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

Source page: https://510kreport.com/device/K000779
Methodology: https://510kreport.com/methodology