FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BlueStar Rx
K Number: K203434
·
Decision Sep 8, 2021
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
54
Applicant Total
11
Review Days
289
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BlueStar Rx
- K Number
- K203434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welldoc, Inc.
- Date Received
- November 23, 2020
- Decision Date
- September 8, 2021
- Product Code
- NDC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NDC | Calculator, Drug Dose | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NDC), ordered by most recent decision date.
Glucommander
FDA 510(k)
FDA Class 2
·Anesthesiology
EndoTool IV Cloud 1.0
FDA 510(k)
FDA Class 2
·Anesthesiology
MiniMed Go App
FDA 510(k)
FDA Class 2
·Anesthesiology
UpDoc
FDA 510(k)
FDA Class 2
·Anesthesiology
T1D1
FDA 510(k)
FDA Class 2
·Anesthesiology
EndoTool IV (3.1)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Welldoc, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222888 | BlueStar CGM insulin dose calculator | Aug 11, 2023 | Substantially Equivalent |
| K230813 | BlueStar and BlueStar Rx | Jul 28, 2023 | Substantially Equivalent |
| K193654 | BlueStar Rx | Apr 7, 2020 | Substantially Equivalent |
| K190013 | WellDoc BlueStar | Nov 4, 2019 | Substantially Equivalent |
| K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Jan 12, 2017 | Substantially Equivalent |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | Nov 22, 2016 | Substantially Equivalent |
| K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | Jul 8, 2014 | Substantially Equivalent |
| K120314 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Feb 24, 2012 | Substantially Equivalent |
| K112370 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | Oct 14, 2011 | Substantially Equivalent |
| K100066 | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 | Jul 15, 2010 | Substantially Equivalent |