510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sotera Wireless

Carlsbad, CA, US

SOTERA WIRELESS appears in FDA device records in Carlsbad, CA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Sotera Wireless between 2012 and 2018. The busiest year on record is 2015, with 4. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sotera Wireless, by decision year
YearClearances
20122
20132
20154
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K180472ViSi Mobile Monitoring SystemMHXSubstantially Equivalent
K152341ViSi Mobile Monitoring SystemMWISubstantially Equivalent
K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorMHXSubstantially Equivalent
K150361ViSi Mobile Monitoring SystemMWISubstantially Equivalent
K143751Visi Mobile Monitoring SystemMWISubstantially Equivalent
K133586VISI MOBILE MONITIORING SYSTEMMWISubstantially Equivalent
K130709VISI MOBILE MONITORING SYSTEMMWISubstantially Equivalent
K122036VISI MOBILE MONITORING SYSTEMMWISubstantially Equivalent
K112478VISI MOBILE MONITORING SYSTEMMWISubstantially Equivalent

Registered establishments

FDA registered establishments for Sotera Wireless, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30096736453009673645SOTERA WIRELESS5841 Edison Place, Carlsbad, CA 92008 US2026and 1 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1818-2013ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 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.Class IITerminated
Z-1817-2013ViSi 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.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain