# K190775: The RHEA Vital Sign Vigilance System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Fiber Medical Technology Co., Ltd.
- Decided: Dec 19, 2019 after 268 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- 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 K910772 (1991). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131379: Earlysense, Earlysense, Ltd. (2013) Summary page 5.

## Indications for use
The RHEA Vital Sign Vigilance System is intended for continuous measurement of respiration rate and heart rate for adults (<150kg), in an automatic contact-less manner, in hospital or clinic setting during sleep or resting condition.

Source page: https://510kreport.com/device/K190775
Methodology: https://510kreport.com/methodology