Welldoc
Columbia, MD, US
WELLDOC appears in FDA device records in Columbia, MD. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Welldoc between 2010 and 2023. The busiest year on record is 2023, with 2. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222888 | BlueStar CGM insulin dose calculator | QRX | Substantially Equivalent | |
| K230813 | BlueStar and BlueStar Rx | NDC | Substantially Equivalent | |
| K203434 | BlueStar Rx | NDC | Substantially Equivalent | |
| K193654 | BlueStar Rx | MRZ | Substantially Equivalent | |
| K190013 | WellDoc BlueStar | MRZ | Substantially Equivalent | |
| K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | MRZ | Substantially Equivalent | |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | MRZ | Substantially Equivalent | |
| K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | MRZ | Substantially Equivalent | |
| K120314 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | MRZ | Substantially Equivalent | |
| K112370 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | MRZ | Substantially Equivalent | |
| K100066 | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 | MRZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008770957 | 3008770957 | WELLDOC | 10221 Wincopin Cir Ste 150, Columbia, MD 21044 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain