# K171836: EarlySense Bed Sensing Unit

- Pathway: 510(k) (Traditional)
- Applicant: Earlysense, Ltd.
- Decided: Jan 4, 2018 after 198 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: 10 generations back to K910772 (1991). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 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.
- K152911: EarlySense Insight Sytem, Earlysense, Ltd. (2016) Summary page 5.

## Indications for use
The EarlySense Bed Sensing Unit is an accessory that is compatible with bedside units of EarlySense Systems (Models 2.0 and InSight) intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner. Environment of use for the accessory is defined as per compatible cleared bedside units labeling: EarlySense 2.0 - at home, in hospital or clinic setting and InSight - in hospital or clinic setting. The device 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 <111 Kg) during sleep and resting condition.

Source page: https://510kreport.com/device/K171836
Methodology: https://510kreport.com/methodology