# K073140: Vitalogik Model 4000/4500

- Pathway: 510(k) (Special)
- Applicant: Mennen Medical, Ltd.
- Decided: Nov 21, 2007 after 14 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 2 generations back to K001120 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052288: Vitalogik, Mennen Medical, Ltd. (2005) Summary page 1.

## Indications for use
VitaLogik 4000/4500 is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik 4000/4500 can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the VitaLogik 4000/4500 to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical VitaLogik 4000/4500 is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. The following are examples of intended clinical applications: O Critical Care Patients o Cardiac Step-down/Telemetry Units O Emergency Departments Intra-operative (Anesthesia) Monitoring O Post Anesthesia Care

Source page: https://510kreport.com/device/K073140
Methodology: https://510kreport.com/methodology