Vitalconnect, Inc.: FDA clearances and approvals
Vitalconnect, Inc. has 10 FDA 510(k) clearances (first 2014, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time: 127 days. Since 2017 its median was 129 days, against 129 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Vitalconnect, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 2 | 162 |
| 2015 | 1 | 125 |
| 2016 | 0 | — |
| 2017 | 2 | 194 |
| 2018 | 0 | — |
| 2019 | 2 | 90 |
| 2020 | 2 | 134 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 269 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Vitalconnect, Inc.'s cleared 510(k)s took a median 129 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 9 | 9 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
Review panels
- Cardiovascular (10)
Most recent Vitalconnect, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242129 | VitalRhythm | DQK | 2025-04-17 | 269 |
| K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) | DRG | 2020-04-20 | 139 |
| K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20 | DRG | 2020-02-06 | 129 |
| K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 | DRG | 2019-06-07 | 59 |
| K183078 | VitalConnect Platform, VitalPatch Biosensor | DRG | 2019-03-07 | 122 |
| K163453 | VitalPatch® VitalConnect Platform | DRG | 2017-11-02 | 328 |
| K170973 | VitalWatch Software User Interface | DRG | 2017-06-02 | 60 |
| K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | DRG | 2015-12-06 | 125 |
| K141167 | VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) | DRG | 2014-07-29 | 84 |
| K132447 | VITALCONNECT PLATFORM BY VITAL CONNECT INC. | DRG | 2014-04-03 | 240 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-05-21.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Vitalconnect, Inc. have?
Vitalconnect, Inc. has 10 FDA 510(k) clearances (first 2014, latest 2025), across 2 product codes in 1 review panel.
How long does FDA take to clear Vitalconnect, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vitalconnect, Inc.'s cleared 510(k)s is 127 days. Since 2017: 129 days, versus 129 days for all cleared 510(k)s in the same product codes.
What devices does Vitalconnect, Inc. make?
Its most frequent FDA product codes are DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 9); DQK (Computer, Diagnostic, Programmable, 1).
Has Vitalconnect, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Vitalconnect, Inc; the most recent began 2020-05-21. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Vitalconnect, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRG, Vitalconnect, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.