# K060230: Dopplex Centrale

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Ltd.
- Decided: Mar 23, 2006 after 52 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- 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 K970456 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970456: Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving System, Hewlett-Packard GmbH (1997) Summary page 2.

## Indications for use
Dopplex Centrale (DCII) is a software package that collects and manages real-time data from a maximum of 48 individual fetal monitors which are connected to a central server by means communication links. Dopplex Centrale is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive and centralised obstetrical surveillance of those maternal patients who are being monitored by otherwise autonomous CTG devices. Fetal heart rate information can be concurrently viewed on up to 50 conveniently sited computers including a central station, patient bedsides, nurses' lounges and physicians' offices. Dopplex Centrale provides an easy to use means of patient surveillance within a perinatal environment within a hospital. A Dopplex Centrale system is specified, supplied, commissioned and maintained exclusively by the manufacturer, Huntleigh Healthcare, or its appointed agents. It provides storage and archiving of FHR traces together with the associated patient details. The specific medical indications for the use of this device is * This device is a prescription device * This device is not intended to contact the patient * This device is used continuously in Obstetrical Departments * Basic fetal trace alerting for antepartum and intrapartum applications * The physiological purpose is indirect. The device is intended to gather and store fetal and maternal information provided by the attached fetal monitors which constitute the primary care sources.

Source page: https://510kreport.com/device/K060230
Methodology: https://510kreport.com/methodology