# K140852: Vectraplex CMS

- Pathway: 510(k) (Traditional)
- Applicant: Vectracor, Inc.
- Decided: Jan 30, 2015 after 302 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933143 (1994). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022507: Datex-Ohmeda S/5 Network and Central '02, Datex-Ohmeda (2002) Summary page 4.
- K080192: Hypervisor VI Central Monitoring System (Including TMS), Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 4.

## Indications for use
Vectraplex® CMS is a Central Monitoring System intended to transfer information between networked devices (only VectraplexECG Systems), which include hard-wired or wireless devices The Central Monitoring System can be used for remote monitor management, printing, viewing or otherwise processing of information from VectraplexECG Systems including remote control The device is intended to be used by qualified medical professionals The Vectraplex CMS will audibly and visually alarm if the VectraplexECG System's CEB® (VectraplexAMI), Cardiac Electrical Biomarker, reaches an alarm condition. The Vectraplex CMS’ intended use population consists of those patients with certain medical conditions in whom continuous cardiac monitoring is considered to be a medical necessity in the judgment of the ordering healthcare provider. The Vectraplex CMS is intended for centralized monitoring of patients through a network in hospitals, Emergency Departments and Surgical Centers, doctor’s offices, and urgent care facilities. Not for home use

Source page: https://510kreport.com/device/K140852
Methodology: https://510kreport.com/methodology