Data / Medical devices / United States / Sotera Wireless
Sotera Wireless: FDA-registered device maker in Carlsbad, CA, United States, 8 510(k) clearances
Sotera Wireless is registered with the FDA (registration 3009673645) in Carlsbad, CA, United States. It lists 11 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 19, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009673645
- Address
- 5841 Edison Place Suite #140, Carlsbad, CA, United States, 92008
- Owner or operator
- Sotera Wireless, Inc. (10040989)
- Roles
- Manufacturer
- First device listed
- June 8, 2012
- Registered through
- 2026
- Brand names listed
- Sotera Visi mobile monitoring system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | CBZ | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Tissue Saturation | MUD | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 19, 2018 | K180472 | ViSi Mobile Monitoring System | MHX | Substantially Equivalent | Sotera Wireless, Inc. | accessdata.fda.gov |
| December 14, 2015 | K152341 | ViSi Mobile Monitoring System | MWI | Substantially Equivalent | Sotera Wireless, Inc. | accessdata.fda.gov |
| July 20, 2015 | K142827 | Visi Mobile Monitoring System, Visi Mobile Chest Sensor | MHX | Substantially Equivalent | Sotera Wireless, Inc. | accessdata.fda.gov |
| August 4, 2014 | K141496 | MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER | MUD | Substantially Equivalent | Reflectance Medical, Inc. | accessdata.fda.gov |
| April 11, 2014 | K133923 | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET | MUD | Substantially Equivalent | Reflectance Medical, Inc. | accessdata.fda.gov |
| December 5, 2012 | K122645 | MOBILE CAREGUIDE 2100 OXIMETER | MUD | Substantially Equivalent | Reflectance Medical, Inc. | accessdata.fda.gov |
| July 26, 2012 | K113656 | CAREGUIDE OXIMETER | MUD | Substantially Equivalent | Reflectance Medical, Inc. | accessdata.fda.gov |
| March 22, 2012 | K112478 | VISI MOBILE MONITORING SYSTEM | MWI | Substantially Equivalent | Sotera Wireless, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 23, 2013 | 65718 | Class II | Terminated | ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. | Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound. | accessdata.fda.gov |
Compare with other makers
- All makers of Detector And Alarm, Arrhythmia
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- All makers of Oximeter
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Continuous Measurement Thermometer
Updated June 19, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.