# K993643: Nexsystem Ambulatory Patient Monitor Model Nex 100

- Pathway: 510(k) (Traditional)
- Applicant: Nexan Telemed, Ltd.
- Decided: Dec 28, 1999 after 61 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K864318 (1987). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980619: Sabratek Patient Home Management System, Sabratek Corp. (1998) Summary page 1.
- K951246: Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options, Protocol Systems, Inc. (1996) Summary page 1.
- K974149: Ambulatory X-12 Telemetry Module, Mortara Instrument, Inc. (1998) Summary page 1.
- K943278: Tracker 2/Tracker 3 Holter Recorder, Reynolds Medical, Ltd. (1994) Summary page 1.
- K951902: Pathfinder 700 Holter Analyzer, Reynolds Medical, Ltd. (1996) Summary page 1.
- K964408: Poseidon Cardiac Monitoring System (PCMS), Instromedix, Inc. (1997) Summary page 1.

## Indications for use
The Nexsystem ambulatory patient monitoring system is intended for use in the home or alternate care settings. It consists of a patient-worn sensor (Nexisensor), signal transfer unit (Nexender), communications module (Nextation), and a telemonitoring station computer based display and storage system (TMS) located at the health care professional’s facility. The device stores and transmits ECG data, respiratory data, skin temperature, systolic and diastolic blood pressure (Non-invasive), and PEF and FEV1. The Nexsystem is not for use as a critical care monitoring system. The Nexsystem is not an apnea monitor.

Source page: https://510kreport.com/device/K993643
Methodology: https://510kreport.com/methodology