# Sotera Wireless, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 9 (2012–2018): 9 510(k) clearances
- Product codes: MWI (7), MHX (2)
- Predicates its devices cite: 19 (10 its own); citations of its devices by later devices: 17 (10 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Welch Allyn Protocol, Inc.: 2 (https://510kreport.com/company/welch-allyn-protocol)
- Nihon Kohden America, Inc.: 1 (https://510kreport.com/company/nihon-kohden-america)
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)
- Monebo Technologies, Inc.: 1 (https://510kreport.com/company/monebo-technologies)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- Cnsystem Medizintechnik AG: 1 (https://510kreport.com/company/cnsystem-medizintechnik)
- Protocol Systems, Inc.: 1 (https://510kreport.com/company/protocol-systems)
- Extension, Inc.: 1 (https://510kreport.com/company/extension)

## Firms that cite its devices most
- Murata Vios, Inc.: 2 (https://510kreport.com/company/murata-vios)
- Vios Medical, Inc.: 2 (https://510kreport.com/company/vios-medical)
- Visiomed Technology Co.,Ltd: 1 (https://510kreport.com/company/visiomed-technology)
- Taiwan Aulisa Medical Devices Technologies, Inc.: 1 (https://510kreport.com/company/taiwan-aulisa-medical-devices-technologies)
- Tosense, Inc.: 1 (https://510kreport.com/company/tosense)

## Its most-cited devices
- K112478: Visi Mobile Monitoring System (2012), cited by 3
- K130709: Visi Mobile Monitoring System (2013), cited by 3
- K143751: Visi Mobile Monitoring System (2015), cited by 3
- K150361: ViSi Mobile Monitoring System (2015), cited by 2
- K122036: Visi Mobile Monitoring System (2012), cited by 2
- K152341: ViSi Mobile Monitoring System (2015), cited by 2

## Recent decisions
- K180472: ViSi Mobile Monitoring System (Jun 19, 2018)
- K152341: ViSi Mobile Monitoring System (Dec 14, 2015)
- K142827: Visi Mobile Monitoring System, Visi Mobile Chest Sensor (Jul 20, 2015)
- K150361: ViSi Mobile Monitoring System (Apr 30, 2015)
- K143751: Visi Mobile Monitoring System (Jan 23, 2015)
- K133586: Visi Mobile Monitioring System (Dec 18, 2013)
- K130709: Visi Mobile Monitoring System (Oct 7, 2013)
- K122036: Visi Mobile Monitoring System (Aug 15, 2012)

Source page: https://510kreport.com/company/sotera-wireless