Data / Medical devices / United States / Welldoc
Welldoc: FDA-registered device maker in Columbia, MD, United States, 4 510(k) clearances
Welldoc is registered with the FDA (registration 3008770957) in Columbia, MD, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 28, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008770957
- Address
- 10221 Wincopin Cir Ste 150, Columbia, MD, United States, 21044
- Owner or operator
- Welldoc (10034724)
- Roles
- Manufacturer
- First device listed
- December 16, 2019
- Registered through
- 2027
- Brand names listed
- BlueStar, BlueStar Rx, BlueStarRx, Conifer Connect Diabetes, Conifer Connect Diabetes Rx, Health Optimizer, Health Optimizer for Rare Condition Members, Lilly Health Personalized Medicine and Health Platform and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Manufacturer | accessdata.fda.gov |
| Calculator, Drug Dose | NDC | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | 1 | Manufacturer | accessdata.fda.gov |
| Continuous Glucose Monitor Secondary Display | PJT | 2 | Manufacturer | accessdata.fda.gov |
| Reminder, Medication | NXQ | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 28, 2023 | K230813 | BlueStar and BlueStar Rx | NDC | Substantially Equivalent | Welldoc, Inc. | accessdata.fda.gov |
| September 8, 2021 | K203434 | BlueStar Rx | NDC | Substantially Equivalent | Welldoc, Inc. | accessdata.fda.gov |
| April 7, 2020 | K193654 | BlueStar Rx | MRZ | Substantially Equivalent | Welldoc, Inc. | accessdata.fda.gov |
| November 4, 2019 | K190013 | WellDoc BlueStar | MRZ | Substantially Equivalent | Welldoc, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Calculator, Drug Dose
- All makers of Accessories, Pump, Infusion
- All makers of Continuous Glucose Monitor Secondary Display
- All makers of Reminder, Medication
- All makers of Continuous Glucose Monitor Retrospective Data Analysis Software
Updated July 28, 2023. 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.