# K092062: Everon 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Earlysense, Ltd.
- Decided: May 24, 2010 after 320 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: 5 generations back to K913396 (1992). 28 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082465: Everon, Earlysense, Ltd. (2009) Summary page 1.
- K041904: Compass F10 System, Medcare Flaga (2004) Summary page 2.
- K082626: PAM 3000, Wireless 2000 RF & Uwb Technologies, Ltd. (2009) Summary page 2.

## Most influential descendants
- K120465: Earlysense (Everon) System (2012), 9 descendants of its own
- K131379: Earlysense (2013), 7 descendants of its own
- K133661: Chair Sensing Unit for Earlysense System (2014), 6 descendants of its own
- K152911: EarlySense Insight Sytem (2016), 5 descendants of its own
- K180079: Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation (2018), 2 descendants of its own

## Indications for use
The EverOn 1.0 system is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, at home, hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EverOn has been studied in children (weight Ž10Kg) and adults (weight <111 Kg) during sleep and resting condition.

Source page: https://510kreport.com/device/K092062
Methodology: https://510kreport.com/methodology