SOTERA WIRELESS

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3009673645

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009673645
FEI Number
3009673645
Entity Name
SOTERA WIRELESS
City/State/Country
Carlsbad, CA, US
Establishment Address
5841 Edison Place, Suite #140, Carlsbad, CA 92008, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Sotera Wireless, Inc. (Owner Number: 10040989)
Owner / Operator Contact Address
5841 Edison Place, Suite #140, Carlsbad, CA 92008, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K141496
PMA Number
N/A

All Registered Proprietary Names

Sotera Visi mobile monitoring system Sotera Visi mobile monitoring system Sotera Visi mobile monitoring system Sotera Visi mobile monitoring system Sotera Visi mobile monitoring system Sotera Visi mobile monitoring system Sotera Visi mobile monitoring system

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2015-08-28
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2015-08-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-04-12
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2019-04-12
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2019-04-12
DQA Oximeter Cardiovascular Class 2 870.2700 2019-04-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-04-12
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2019-04-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-12-16
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2015-12-16
DQA Oximeter Cardiovascular Class 2 870.2700 2015-12-16
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2015-12-16
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2015-12-16
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2015-12-16
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2015-08-28
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2017-08-16
CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling Anesthesiology Class 2 868.1170 2015-08-28
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2015-08-28

Official Correspondent

Andrew Nguyen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sotera Wireless, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201432 Masimo Corporation Masimo O3 Regional Oximeter System 2020-08-29
K211561 Covidien, LLC INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) 2021-12-05
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2025 Philips North America Llc 2
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026 Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom 2
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual

Similar Registrations

Registration Number Establishment Name Location
3009156722 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Shenzhen Guangdong, CN
3007616088 JIANGYIN SINBON ELECTRONICS CO LTD Jiangyin Jiangsu, CN
3010611950 Natus Neurology Incorporated Middleton, WI, US
3004105270 PLEXUS CORP. BUFFALO GROVE, IL, US
1651104 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES EL PASO, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009673645. Last updated year: 2026. Please use registration number 3009673645 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.