FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tandem Mobi insulin pump with interoperable technology
K Number: K253074
·
Decision Nov 6, 2025
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
25
Review Days
44
Basic Information
- Device Name
- Tandem Mobi insulin pump with interoperable technology
- K Number
- K253074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5730
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tandem Diabetes Care, Inc.
- Date Received
- September 23, 2025
- Decision Date
- November 6, 2025
- Product Code
- QFG
- 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 |
|---|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | FDA class 2 | Clinical Chemistry |
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Other Clearances by Tandem Diabetes Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260429 | Control-IQ+ technology | Apr 24, 2026 | Substantially Equivalent |
| K250792 | t:slim X2 insulin pump with interoperable technology | Sep 24, 2025 | Substantially Equivalent |
| K250798 | Control-IQ+ technology | May 21, 2025 | Substantially Equivalent |
| K243823 | Control-IQ+ technology | Feb 24, 2025 | Substantially Equivalent |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology | Jul 26, 2024 | Substantially Equivalent |
| K240309 | Tandem Mobi insulin pump with interoperable technology | Mar 21, 2024 | Substantially Equivalent |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Nov 3, 2023 | Substantially Equivalent |
| K232382 | Control-IQ Technology | Nov 3, 2023 | Substantially Equivalent |
| K233044 | Tandem Mobi insulin pump with interoperable technology | Oct 5, 2023 | Substantially Equivalent |
| K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | Jul 10, 2023 | Substantially Equivalent |