# K092153: Skyline 55, Model Ver 1

- Pathway: 510(k) (Traditional)
- Applicant: Larsen & Toubro Limited
- Decided: Nov 20, 2009 after 127 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- 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: 2 generations back to K011093 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081552: Skyline 55, Larsen & Toubro Limited (2008) Summary page 1.
- K062194: Hypervisor VI Central Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.

## Indications for use
The Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of continuous monitoring along with extended features in which 72-hour trend data can be stored for each patient and displayed in the form of Waveform recall, Graphical and Tabular Trends. Alarm records for 72-hours too are recorded and stored for each patient connected to the system software. Skyline 55 Ver1 is intended to conduct centralized monitoring for adult, pediatric and neonatal patients' vital sign information from multiple monitors in a hospital, the monitoring parameters include ECG, NIBP, SPO2, RESP, IBP, TEMP, C02 and Anesthesia agents. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The system software permits patient monitoring with adjustable visible and audible alarm signals. The system software is not intended for home use.

Source page: https://510kreport.com/device/K092153
Methodology: https://510kreport.com/methodology