# Earlysense, Ltd.

- Location (FDA's records): Ramat-Gan, IL
- FDA decisions: 12 (2007–2018): 12 510(k) clearances
- Product codes: BZQ (8), MSX (4)
- Predicates its devices cite: 22 (12 its own); citations of its devices by later devices: 18 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wireless 2000 RF & Uwb Technologies, Ltd.: 2 (https://510kreport.com/company/wireless-2000-rf-uwb-technologies)
- Medcare Flaga: 2 (https://510kreport.com/company/medcare-flaga)
- Vivometrics, Inc.: 2 (https://510kreport.com/company/vivometrics)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- Ferguson Medical: 1 (https://510kreport.com/company/ferguson-medical)
- Nonin Medical, Inc.: 1 (https://510kreport.com/company/nonin-medical)

## Firms that cite its devices most
- Hill-Rom, Inc.: 1 (https://510kreport.com/company/hill-rom)
- Zyter, Inc.: 1 (https://510kreport.com/company/zyter)
- Taiwan Aulisa Medical Devices Technologies, Inc.: 1 (https://510kreport.com/company/taiwan-aulisa-medical-devices-technologies)
- Shenzhen Fiber Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-fiber-medical-technology)
- Wireless 2000 RF & Uwb Technologies, Ltd.: 1 (https://510kreport.com/company/wireless-2000-rf-uwb-technologies)
- Intelligent Dots, LLC: 1 (https://510kreport.com/company/intelligent-dots)

## Its most-cited devices
- K152911: EarlySense Insight Sytem (2016), cited by 3
- K131379: Earlysense (2013), cited by 3
- K151006: EarlySense Central Display Station (CDS) (2015), cited by 2
- K070375: Earlysense ES-16 System (2007), cited by 2
- K120465: Earlysense (Everon) System (2012), cited by 2
- K110521: Everon Central Display Station (CDS) (2011), cited by 1

## Recent decisions
- K171836: EarlySense Bed Sensing Unit (Jan 4, 2018)
- K152911: EarlySense Insight Sytem (May 6, 2016)
- K151006: EarlySense Central Display Station (CDS) (Aug 31, 2015)
- K133661: Chair Sensing Unit for Earlysense System (Jun 13, 2014)
- K131379: Earlysense (Dec 18, 2013)
- K121885: Earlysense Central Display System (Sep 10, 2012)
- K120465: Earlysense (Everon) System (Jun 8, 2012)
- K110521: Everon Central Display Station (CDS) (Apr 19, 2011)

Source page: https://510kreport.com/company/earlysense