# K131379: Earlysense - Pathway: 510(k) (Traditional) - Applicant: Earlysense, Ltd. - Decided: Dec 18, 2013 after 218 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. 7 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) - 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 2.0 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 i10 Kg) and adults (weight