# K220989: Next Generation NetKonnect

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden Digital Health Solutions, Inc.
- Decided: Jul 29, 2022 after 116 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K951127 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112637: Netkonnect Remote Network Extension, Nihon Kohden (2011) Summary page 5.

## Indications for use
Next Generation NetKonnect is intended to interface the Nihon Kohden monitoring network with networked client PCs to annunciate and display patient monitoring information to healthcare providers. The device is intended for use in near real-time monitoring of routing patient status and alarm events. Next Generation NetKonnect supplements the primary patient monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and event related information including vital signs values and waveforms. The system is intended for use on any patients as determined by qualified medical personnel within a hospital or clinical environment.

Source page: https://510kreport.com/device/K220989
Methodology: https://510kreport.com/methodology