Company · US
Vitalconnect, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2025 | K242129 | VitalRhythm Vitalconnect, Inc. | DQK |
| Apr 20, 2020 | K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) Vitalconnect, Inc. | DRG |
| Feb 6, 2020 | K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D B Vitalconnect, Inc. | DRG |
| Jun 7, 2019 | K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 Vitalconnect, Inc. | DRG |
| Mar 7, 2019 | K183078 | VitalConnect Platform, VitalPatch Biosensor Vitalconnect, Inc. | DRG |
| Nov 2, 2017 | K163453 | VitalPatch® VitalConnect Platform Vitalconnect, Inc. | DRG |
| Jun 2, 2017 | K170973 | VitalWatch Software User Interface Vitalconnect, Inc. | DRG |
| Dec 6, 2015 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch Vitalconnect, Inc. | DRG |
| Jul 29, 2014 | K141167 | VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) Vitalconnect, Inc. | DRG |
| Apr 3, 2014 | K132447 | VITALCONNECT PLATFORM BY VITAL CONNECT INC. Vitalconnect, Inc. | DRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | Vitalconnect Inc. VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring syst Terminated |
DRG | K193343 |