# K170538: RVS-100 Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Rudolf Riester GmbH
- Decided: Oct 17, 2017 after 236 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: 17 generations back to K941811 (1994). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153135: Vital Signs Monitor, Guangdong Biolight Meditech Co., Ltd. (2016) Summary page 5.

## Indications for use
The RVS-100 vital signs monitor is intended to be used for monitoring, displaying, reviewing, storing and sending alarms regarding multiple physiological patient parameters, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (Temp). The RVS-100 vital signs monitor is intended to be used in controlled, hospital environments. It is not intended for helicopter transport, hospital ambulance or home use.

Source page: https://510kreport.com/device/K170538
Methodology: https://510kreport.com/methodology