# K070375: Earlysense ES-16 System

- Pathway: 510(k) (Traditional)
- Applicant: Earlysense, Ltd.
- Decided: Nov 15, 2007 after 280 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: 2 generations back to K830295 (1983). 14 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024322: Embla N7000, Medcare Flaga (2003) Summary page 2.
- K971813: EMBLA, Ferguson Medical (1998) Summary page 2.
- K011903: Lifeshirt System with Vivologic Analysis Software, Vivometrics, Inc. (2002) Summary page 2.

## Most influential descendants
- K082626: PAM 3000 (2009), 21 descendants of its own
- K082465: Everon (2009), 11 descendants of its own
- K092062: Everon 1.0 (2010), 10 descendants of its own
- K202464: Vital Sign Monitoring Sensor (Model :XK300) (2021), 9 descendants of its own
- K120465: Earlysense (Everon) System (2012), 9 descendants of its own

## Indications for use
The EarlySenseTM ES-16 system is intended for continuous measurement of respiration rate and heart rate, 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 ES-16 System has been studied in children (weight Ž>10 Kg) and adults (weight <111 Kg) during sleep and resting condition.

Source page: https://510kreport.com/device/K070375
Methodology: https://510kreport.com/methodology