BlueStar and BlueStar Rx
FDA 510(k) K230813 · Welldoc, Inc.
510(k) numberK230813
Submission
- Device name
- BlueStar and BlueStar Rx
- Applicant
- Welldoc, Inc.
Columbia, MD, US - Received
- March 24, 2023
- Decision date
- July 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDC – Calculator, Drug Dose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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|---|---|---|---|
| K254102 | GlucommanderNDC · Traditional | Glytec, LLC | 05/27/2026SE |
| K260910 | EndoTool IV Cloud 1.0NDC · Traditional | Glooko, Inc. | 05/01/2026SE |
| K253512 | MiniMed Go AppNDC · Traditional | Medtronic Minimed | 01/08/2026SE |
| K253281 | UpDocNDC · Traditional | Updoc, Inc. | 12/23/2025SE |
| K252104 | T1D1NDC · Traditional | Comerge AG | 08/20/2025SE |
| K241088 | EndoTool IV (3.1)NDC · Traditional | Monarch Medical Technologies | 12/11/2024SE |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC · Traditional | Medtronic Minimed | 11/12/2024SE |
| K242066 | iSage RxNDC · Traditional | Amalgam Rx, Inc. | 08/21/2024SE |
| K232451 | Insulia Bolus CompanionNDC · Traditional | Voluntis Sa. | 12/12/2023SE |
| K221924 | Digital RoutinesNDC · Traditional | Gnc Holdings, LLC | 03/15/2023SE |
More from Gnc Holdings, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K222888 | BlueStar CGM insulin dose calculatorQRX · Traditional | 08/11/2023SE |
| K203434 | BlueStar RxNDC · Traditional | 09/08/2021SE |
| K193654 | BlueStar RxMRZ · Traditional | 04/07/2020SE |
| K190013 | WellDoc BlueStarMRZ · Traditional | 11/04/2019SE |
| K162532 | WellDoc BlueStar, WellDoc BlueStar RxMRZ · Traditional | 01/12/2017SE |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemMRZ · Traditional | 11/22/2016SE |
| K141273 | Welldoc Diabetesmanager System and Diabetesmanager- RX SysteMRZ · Special | 07/08/2014SE |
| K120314 | Welldoc Diabetes Manager System and Diabetes Manager RX SystemMRZ · Special | 02/24/2012SE |
| K112370 | Welldoc Diabetes Manager System and Diabetes Manager RX SystemMRZ · Special | 10/14/2011SE |
| K100066 | Diabetesmanager System, Diabetesmanager-Rx System Model Version 1.1MRZ · Traditional | 07/15/2010SE |
Questions and answers
When was BlueStar and BlueStar Rx cleared by the FDA?
BlueStar and BlueStar Rx (K230813) received a 510(k) decision of Substantially Equivalent on July 28, 2023, 126 days after the submission was received.
What is the product code of K230813?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.