# K050128: Vitalware VMS

- Pathway: 510(k) (Traditional)
- Applicant: Televital, Inc.
- Decided: May 13, 2005 after 114 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K941811 (1994). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012171: Modification to: Argus System-Continuous Expert Care Network W/Smart Alrams, Visicu, Inc. (2001) Summary page 1.
- K001972: Argus System-Continuous Expert Care Network, Visicu, Inc. (2000) Summary page 1.
- K000276: MPT 24 and Vital View 24, Criticare Systems, Inc. (2000) Summary page 1.
- K041741: M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry System II Including M4841A Patien, Philips Medical Systems, Inc. (2004) Summary page 1.

## Indications for use
The TeleVital VitalWare VMS is a vital sign monitoring and patient information software product intended to be used in conjunction with independent monitoring devices, and ancillary systems for the real-time collection, storage, and transmission to remote viewing sites. The system is intended to be used in a hospital or clinic environment. Clinical judgment and experience are required to check and interpret the information delivered. VitalWare VMS is not intended to, and is not capable of controlling any of the medical devices it interfaces with.

Source page: https://510kreport.com/device/K050128
Methodology: https://510kreport.com/methodology