# K971038: Kontron Kolormon Plus Ecg with Respiration Module

- Pathway: 510(k) (Traditional)
- Applicant: Kontron Instruments, Ltd.
- Decided: Sep 24, 1997 after 188 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The 7271-500 module monitors ECG and Respiration, and the results are displayed on a Kolormon host system. The ECG and respiration are measured from a 3 lead system providing an ECG waveform and heart rate from one of three selectable ECG vectors as well as a respiration waveform and respiration rate. Respiration is also measured from the active ECG electrode pair. There are two AC coupled sources of power to the front end to power the ECG and respiration circuits. Current is injected into the patient through the ECG electrades to detect when a lead falls off the patieat and through the respiration electrodes to determine the thoracic impedance across the chest to which the respiration cycle correlates. Measurement of the ECG waveform is by potential difference between two of three possible electrodes. The electrode pair is user selected. The module may be used on either adults or neonates by selecting the adult/neonate option link in the module. The Kolormon system is a generic patient monitor used in the operating theatre, critical care unit or as a bedside monitor on the ward. Its purpose is to measure and display clinical parameters of a patient via the module and module housing. The basic system comprises a host monitor and its module housing. Modules, capable of measuring one or more clinical parameters of a patient to which they are connected, may be inserted into the module housing from which the clinical parameters for that module will be monitored. The generic nature of the system comes from the ability to select clinical parameters for monitoring by insertion of the appropriate modules. The host has a colour screen which displays up to 6 waveforms, numeric values of the clinical parameters monitored (termed derived parameters), trends of clinical parameters, messages (information/cautions and warnings) and labels for keys used to select functions of the modules. There are a set of keys which control the basic functions of the monitor and a strip of six trikeys used to select module functions. Sets of key labels are presented at the bottom of the screen defined by the module whose keys have been selected for display and the previous key selections for that module.

Source page: https://510kreport.com/device/K971038
Methodology: https://510kreport.com/methodology