Vitalconnect Inc.
FDA Regulatory Profile
Vitalconnect Inc. appears in FDA public data with 1 recall, 10 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2537-2020, Class II) was initiated on May 21, 2020. Its most recent 510(k) clearance was granted on April 17, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 10
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2537-2020 | Class II | VistaSolution, physiological signal transmitter. A software graphical user interface for use by hea | May 21, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242129 | VitalRhythm | April 17, 2025 |
| K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) | April 20, 2020 |
| K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of | February 6, 2020 |
| K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 | June 7, 2019 |
| K183078 | VitalConnect Platform, VitalPatch Biosensor | March 7, 2019 |
| K163453 | VitalPatch® VitalConnect Platform | November 2, 2017 |
| K170973 | VitalWatch Software User Interface | June 2, 2017 |
| K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | December 6, 2015 |
| K141167 | VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER S | July 29, 2014 |
| K132447 | VITALCONNECT PLATFORM BY VITAL CONNECT INC. | April 3, 2014 |