Data / Medical devices / United States / VitalConnect, Inc.
VitalConnect, Inc.: FDA-registered device maker in San Jose, CA, United States, 2 510(k) clearances
VitalConnect, Inc. is registered with the FDA (registration 3022123357) in San Jose, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 20, 2020. 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
- 3022123357
- FEI number
- 3010830833
- Address
- 2870 Zanker Road Suite 100, San Jose, CA, United States, 95134
- Owner or operator
- VitalConnect, Inc. (10046585)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor
- First device listed
- March 11, 2019
- Registered through
- 2026
- Brand names listed
- VistaSolution, VitalConnect Platform, VitalPatch Adhesive Overlay, VitalPatch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor | 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 |
|---|---|---|---|---|---|---|
| April 20, 2020 | K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) | DRG | Substantially Equivalent | Vitalconnect, Inc. | accessdata.fda.gov |
| February 6, 2020 | K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20 | DRG | Substantially Equivalent | Vitalconnect, 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 21, 2020 | 85802 | Class II | Terminated | VistaSolution, 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 sett | 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 | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Detector And Alarm, Arrhythmia
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Tape And Bandage, Adhesive
Updated July 10, 2020. 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.