Welldoc, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Welldoc, Inc.” (first 2010, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 125 days. Since 2017 the median was 208 days, against 128 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 23 |
| 2013 | 0 | — |
| 2014 | 1 | 53 |
| 2015 | 0 | — |
| 2016 | 1 | 106 |
| 2017 | 1 | 125 |
| 2018 | 0 | — |
| 2019 | 1 | 305 |
| 2020 | 1 | 99 |
| 2021 | 1 | 289 |
| 2022 | 0 | — |
| 2023 | 2 | 224 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Welldoc, Inc. took a median 208 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | 8 | 8 |
| NDC | Calculator, Drug Dose | 2 | 2 |
| QRX | Continuous Glucose Monitor Informed Insulin Dose Calculator | 1 | 1 |
Review panels
Most recent Welldoc, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222888 | BlueStar CGM insulin dose calculator | QRX | 2023-08-11 | 322 |
| K230813 | BlueStar and BlueStar Rx | NDC | 2023-07-28 | 126 |
| K203434 | BlueStar Rx | NDC | 2021-09-08 | 289 |
| K193654 | BlueStar Rx | MRZ | 2020-04-07 | 99 |
| K190013 | WellDoc BlueStar | MRZ | 2019-11-04 | 305 |
| K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | MRZ | 2017-01-12 | 125 |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | MRZ | 2016-11-22 | 106 |
| K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | MRZ | 2014-07-08 | 53 |
| K120314 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | MRZ | 2012-02-24 | 23 |
| K112370 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | MRZ | 2011-10-14 | 58 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Welldoc, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Welldoc, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05343065: A Continuous Glucose Monitor Based Insulin Bolus Calculator (CGM-IBC) Study B (Completed, started 2022-07-05)
- NCT05229445: A Continuous Glucose Monitor Based Insulin Bolus Calculator (Completed, started 2022-07-05)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Welldoc, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRZ)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via MRZ)
Frequently asked questions
How many FDA 510(k) clearances are listed under Welldoc, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Welldoc, Inc.” (first 2010, latest 2023), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Welldoc, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Welldoc, Inc. is 125 days. Since 2017: 208 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Welldoc, Inc.?
The most frequent FDA product codes under this applicant name are MRZ (Accessories, Pump, Infusion, 8); NDC (Calculator, Drug Dose, 2); QRX (Continuous Glucose Monitor Informed Insulin Dose Calculator, 1).
Next steps
- See all 11 Welldoc, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MRZ, Welldoc, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.