WellDoc BlueStar, WellDoc BlueStar Rx
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- BlueStar Rx EUDAMED
- Model / Reference
- 202101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B5532021010 EUDAMED
- Basic UDI-DI
- ++B553BlueStarGC EUDAMED
- Direct Marketing DI
- B5532021010 EUDAMED
- 510(k) Number
- K162532 FDA 510(k)
- FDA Product Code
- MRZ FDA 510(k)
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The WellDoc BlueStar and WellDoc BlueStar Rx are Infusion Pumps, Insulin designed for subcutaneous delivery of insulin in the management of type 2 diabetes. These devices automate insulin dosing and monitoring to support glycemic control in adult patients.
Supplied as a non-sterile, reusable system, the BlueStar integrates with connected devices for automated data transfer and insulin adjustment. It operates in hospital and outpatient settings, adhering to FDA 510(k) clearance and EU MDR requirements. Multiple registration numbers (e.g., 3003098013) and product codes (MRZ) identify its regulatory classification under device class II. Storage and handling follow manufacturer guidelines for reusable medical devices.
Frequently asked questions
What types of healthcare settings can the WellDoc BlueStar be used in, and how does it differ from other insulin infusion pumps?
The WellDoc BlueStar is designed for use in both hospital and outpatient settings, making it versatile for managing type 2 diabetes in adult patients. Unlike some insulin pumps that are single-use or disposable, the BlueStar is supplied as a reusable system, which may reduce costs and waste over time. It automates insulin dosing and integrates with connected devices to support glycemic control through real-time monitoring and adjustments, distinguishing it from traditional pumps that may lack this level of automation and connectivity.
Is the WellDoc BlueStar system sterile when received, and what are the storage requirements for maintaining its condition?
The WellDoc BlueStar is supplied as a non-sterile reusable system, meaning it requires proper cleaning and sterilization between uses. Storage and handling must follow the manufacturer’s guidelines for reusable medical devices to ensure safety and functionality. This includes keeping it in a clean, dry environment and adhering to any specific protocols provided by WellDoc to prevent contamination or damage.
What regulatory pathways does the WellDoc BlueStar follow, and how does this affect its use in different markets?
The WellDoc BlueStar has undergone FDA 510(k) clearance and complies with EU MDR (Medical Device Regulation) requirements, ensuring it meets stringent safety and performance standards in both the U.S. and European markets. Its classification as a Class II device under the FDA’s regulatory framework indicates it has moderate risk and requires specific documentation for compliance. This regulatory route ensures the device is suitable for use in clinical settings where glycemic control is critical for type 2 diabetes management.
Are there different models or sizes available for the WellDoc BlueStar, and how might this affect patient selection?
While the provided data does not specify exact sizes or distinct models beyond the BlueStar and BlueStar Rx, the device is categorized under product code MRZ and multiple registration numbers, suggesting variations may exist for different clinical needs. However, the core functionality—automated insulin dosing and monitoring—remains consistent. Clinicians should refer to WellDoc’s documentation to determine which model best fits their patient’s requirements, such as insulin delivery capacity or connectivity features.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Welldoc Bluestar or Welldoc Diabetesmanager System And, Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning ..., Login | Welldoc, Welldoc App - Digital Therapeutics Alliance
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162532 | Class II | Active |
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Manufacturer
- Manufacturer
- Welldoc, Inc.
Sources (2)
- FDA 510(k) K162532 24 fields · synced Sep 18, 2026
- EUDAMED 013fa12e-99ff-42b2-9aed-74383919026d 61 fields · synced Jul 10, 2026