# K082465: Everon

- Pathway: 510(k) (Traditional)
- Applicant: Earlysense, Ltd.
- Decided: Mar 25, 2009 after 210 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: 3 generations back to K830295 (1983). 15 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070375: Earlysense ES-16 System, Earlysense, Ltd. (2007) Summary page 1.

## Most influential descendants
- K092062: Everon 1.0 (2010), 10 descendants of its own
- 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

## Indications for use
The EverOn (modified EarlySense TM ES-16) system is intended for continuous measurement of respiration rate and heart rate, 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 Ž10 Kg) and adults (weight _111 Kg) during sleep and resting condition.

Source page: https://510kreport.com/device/K082465
Methodology: https://510kreport.com/methodology