FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SmartGuard Technology; Predictive Low Glucose Technology
K Number: K253701
·
Decision Feb 3, 2026
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
19
Applicant Total
48
Review Days
71
Basic Information
- Device Name
- SmartGuard Technology; Predictive Low Glucose Technology
- K Number
- K253701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1356
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Minimed
- Date Received
- November 24, 2025
- Decision Date
- February 3, 2026
- Product Code
- QJI
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| QJI | Interoperable Automated Glycemic Controller | FDA class 2 | Clinical Chemistry |
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