# K152911: EarlySense Insight Sytem

- Pathway: 510(k) (Traditional)
- Applicant: Earlysense, Ltd.
- Decided: May 6, 2016 after 217 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: 9 generations back to K910772 (1991). 53 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 59 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 4.
- K133661: Chair Sensing Unit for Earlysense System, Earlysense, Ltd. (2014) Summary page 4.
- K082626: PAM 3000, Wireless 2000 RF & Uwb Technologies, Ltd. (2009) Summary page 4.

## Most influential descendants
- 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
- K171836: EarlySense Bed Sensing Unit (2018), 0 descendants of its own

## Indications for use
The EarlySense InSight System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in 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.

Source page: https://510kreport.com/device/K152911
Methodology: https://510kreport.com/methodology