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

San Jose, CA, US

VitalConnect, Inc. appears in FDA device records in San Jose, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 10 510(k) clearances for VitalConnect, Inc. between 2014 and 2025. The busiest year on record is 2014, with 2. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for VitalConnect, Inc., by decision year
YearClearances
20142
20151
20172
20192
20202
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242129VitalRhythmDQKSubstantially Equivalent
K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)DRGSubstantially Equivalent
K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20DRGSubstantially Equivalent
K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20DRGSubstantially Equivalent
K183078VitalConnect Platform, VitalPatch BiosensorDRGSubstantially Equivalent
K163453VitalPatch® VitalConnect PlatformDRGSubstantially Equivalent
K170973VitalWatch Software User InterfaceDRGSubstantially Equivalent
K152139Vital Connect Platform, HealthPatch MD, VitalPatchDRGSubstantially Equivalent
K141167VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)DRGSubstantially Equivalent
K132447VITALCONNECT PLATFORM BY VITAL CONNECT INC.DRGSubstantially Equivalent

Registered establishments

FDA registered establishments for VitalConnect, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30221233573010830833VitalConnect, Inc.2870 Zanker Road, San Jose, CA 95134 US2026

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-2537-2020VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring.A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was found. A software defect was encountered causing the lack of notification. The defect could result in exposing a patient to potential hypoxia for a short window of time. The firm is correcting the software to bring the performance back into compliance with specifications.Class IITerminated

Verification record

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