# K191989: WVSM (Wireless Vital Signs Monitor) RWC + miniCap

- Pathway: 510(k) (Traditional)
- Applicant: Athena Gtx
- Decided: Jan 29, 2020 after 188 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: 9 generations back to K962603 (1997). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101674: WVSM (Wireless Vital Signs Monitor), Model 5.0, Athena Gtx (2010) Summary page 4.

## Indications for use
The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2, with an optional accessory for capnography (ETCO2, FiCO2, RR). It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer. The monitor is intended to be used by trained healthcare providers.

Source page: https://510kreport.com/device/K191989
Methodology: https://510kreport.com/methodology