# K120465: Earlysense (Everon) System

- Pathway: 510(k) (Traditional)
- Applicant: Earlysense, Ltd.
- Decided: Jun 8, 2012 after 114 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: 7 generations back to K910772 (1991). 50 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092062: Everon 1.0, Earlysense, Ltd. (2010) Summary page 1.
- K040589: Modification to Avant 9600 Pulse Oximeter, Nonin Medical, Inc. (2004) Summary page 1.
- K011903: Lifeshirt System with Vivologic Analysis Software, Vivometrics, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K202018: Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation (2021), 1 descendant of its own

## Indications for use
The EarlySense (Ever~h) 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 EarlySense has been studied in children (weight 10 Kg) and adults (weight <111 Kg) during sleep and resting condition. In addition, EarlySense (Ever~n) System can continuously monitor oxygen saturation of arterial hemoglobin (5P02) using pulse oximetry in pediatric (ages 2 years and older), adolescents, and adults at home, hospital, or clinical settings.

Source page: https://510kreport.com/device/K120465
Methodology: https://510kreport.com/methodology