# K052288: Vitalogik

- Pathway: 510(k) (Special)
- Applicant: Mennen Medical, Ltd.
- Decided: Dec 20, 2005 after 119 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: 1 generation back to K001120 (2001). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001120: Envoy Patient Monitor, Mennen Medical, Ltd. (2001) Summary page 3.

## Most influential descendants
- K073140: Vitalogik Model 4000/4500 (2007), 0 descendants of its own
- K070254: Horizon SE (2007), 0 descendants of its own

## Indications for use
VitaLogik is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik 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 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 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: * Critical Care Patients * Cardiac Step-down/Telemetry Units * Emergency Departments * Intra-operative (Anesthesia) Monitoring * Post Anesthesia Care

Source page: https://510kreport.com/device/K052288
Methodology: https://510kreport.com/methodology