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VitalConnect, Inc.

United States·US-MF-000010637

Last updated September 17, 2026

Information

Country: United States
Address: 2870, Zanker Road, San Jose, United States
Website: www.vitalconnect.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 408 963 4600
PRRC Contact: Edward Sinclair
EUDAMED SRN: US-MF-000010637
FDA FEI Number: 3010830833
DUNS Number: —

Catalogue (41)

Device	Model / Reference	Registries	Class	Status
VitalPatch® Active Biosensor	3012-01	FDA UDI	Class II	Active
Vista Solution® 30-day Monitoring Kit	9430-01	FDA UDI	Class II	Active
"VitalPatch™ Active Patch	3002-01	FDA UDI	Class II	Unknown
VistaCenter	6200-01	FDA UDI	Class II	Active
HealthPatch® MD Gentle Patch	1001-01	FDA UDI	Class II	Unknown
HealthPatch® MD Active Patch	1002-01	FDA UDI	Class II	Unknown
Vista Solution® 2.0 10-day Evaluation Kit	9510-01	FDA UDI	Class II	Active
Vista Solution® 10-day Evaluation Kit	9410-01	FDA UDI	Class II	Active
VistaPhone	8303-03	FDA UDI	Class II	Active
VistaTablet	8103-01	FDA UDI	Class II	Active
VistaTablet	8101-01	FDA UDI	Class II	Active
VistaHub-WiFi	8001-01	FDA UDI	Class II	Active
VistaTablet	8203-01	FDA UDI	Class II	Active
VistaCenter	6200-03	FDA UDI	Class II	Active
Holter Kit (Wi-Fi Only)	2400-01	FDA UDI	Class II	Active
Vista Solution 3 10-day Evaluation Kit	9610	FDA UDI	Class II	Active
VitalPatch 2.0	3037-01	FDA UDI	Class II	Active
VistaPhone	8303-02	FDA UDI	Class II	Active
VistaPhone	8303-01	FDA UDI	Class II	Active
VistaTablet™ 2.0 RELAY (W/O VCI Box)	8102-01	FDA UDI	Class II	Active
VistaPhone Compact Cardiac Monitoring Kit	1500-01	FDA UDI	Class II	Active
VistaTablet™ 2.0 (Boxed)	8102-01	FDA UDI	Class II	Active
VitalPatch™ 2.0 Single	3035-01	FDA UDI	Class II	Active
HealthPatch® MD Module	1025-01	FDA UDI	Class II	Unknown
VistaPoint Software User Interface	6100-03	FDA UDI	Class II	Active
VistaPoint Software User Interface	6100-01	FDA UDI	Class II	Active
VitalConnect 14-day Cardiac Monitoring Kit	1400-02	FDA UDI	Class II	Active
"VitalPatch™ Gentle Patch	3001-01	FDA UDI	Class II	Unknown
VitalPatch® RTM	4007-01	FDA UDI	Class II	Active
VitalPatch Adhesive Overlay	3801-01	EUDAMEDFDA UDI	Class I	Active
VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20	K192757	FDA 510(k)	Class II	Active
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)	K193343	FDA 510(k)	Class II	Active
VitalConnect Platform, VitalPatch Biosensor	K183078	FDA 510(k)	Class II	Active
VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20	K190916	FDA 510(k)	Class II	Active
VitalRhythm	K242129	FDA 510(k)	Class II	Active
VitalPatch® VitalConnect Platform	K163453	FDA 510(k)	Class II	Active
Vitalconnect Platform (consisting Of Vitalconnect Sensor, Relay Software Library And Secure Server Software Library)	K141167	FDA 510(k)	Class II	Active
VitalWatch Software User Interface	K170973	FDA 510(k)	Class II	Active
Vital Connect Platform, HealthPatch MD, VitalPatch	K152139	FDA 510(k)	Class II	Active
Vitalconnect Platform By Vital Connect Inc.	K132447	FDA 510(k)	Class II	Active
VitalPatch	3037-01	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

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Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 21, 2020	Z-2537-2020	—	terminated	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.