# K133661: Chair Sensing Unit for Earlysense System

- Pathway: 510(k) (Traditional)
- Applicant: Earlysense, Ltd.
- Decided: Jun 13, 2014 after 196 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: 8 generations back to K910772 (1991). 51 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120465: Earlysense (Everon) System, Earlysense, Ltd. (2012) Summary page 2.

## Most influential descendants
- 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
- K253274: BedDot (G1) (2026), 0 descendants of its own
- K223246: Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense (2022), 0 descendants of its own

## Indications for use
The EarlySense Chair Sensing Unit is intended to be used for continuous measurement of Respiration Rate, Heart Rate and Movement, in an automatic contact-less manmer, at horn; hospital or clinic setting. The sensor is indicated for use in children, adolescents and adults. The operation of the EarlySense system has been studied in children (weight ?: 10 Kg) and adults (weight <1I I Kg) during sleep and resting condition, The Chair Sensing Unit can be used with bedside units that contain appropriate software (graphical interface) that can support reading and displaying EarlySense Chair Sensing Unit readings. In addition, the EarlySense System call continuously monlitor oxygen saturation of arterial hemoglobin (SpO 2) using pulse oxinietry in pediatric (ages 2 years and oider), adolescents and adults at home, hospital, or clinical settings.

Source page: https://510kreport.com/device/K133661
Methodology: https://510kreport.com/methodology