510(k) · Cleared
ClearedWelldoc Diabetes Manager System and Diabetes Manager RX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welldoc, Inc. · MRZ Accessories, Pump, Infusion
Cleared on Feb 24, 2012 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 24, 2012
- Review
- 23 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The DiabetesManager® System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager® System analyzes and reports blood glucose test results and supports…
Read the full statement (272 words)
DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The DiabetesManager® System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The DiabetesManager® System is not intended to replace the care pfovided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager®-Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The DiabetesManager®-Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager®-Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the DiabetesManager®-Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The DiabetesManager®-Rx System is not intended to replace the care provided by a Licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120314: Welldoc Diabetes Manager System and Diabetes Manager RX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120314
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026