K250792
- 510(k) number
- K250792
- Device name
- t:slim X2 insulin pump with interoperable technology
- Applicant
- Tandem Diabetes Care, Inc. CA · US
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2025-09-24
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K250792.pdf
Official FDA record: K250792
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.