510(k) K232380
K232380 is an FDA 510(k) premarket notification submitted by Tandem Diabetes Care, Inc. for the device "t:slim X2 Insulin Pump with Interoperable Technology". The FDA issued a decision of Substantially Equivalent on November 3, 2023. The device falls under product code QFG (Alternate Controller Enabled Insulin Infusion Pump), a Class II device regulated under 21 CFR 880.5730. Tandem Diabetes Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2023
- Date Received
- August 8, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alternate Controller Enabled Insulin Infusion Pump
- Device Class
- Class II
- Regulation Number
- 880.5730
- Review Panel
- CH
- Submission Type
An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.