510(k) K231485
K231485 is an FDA 510(k) premarket notification submitted by Beta Bionics, Inc. for the device "iLet® ACE Pump". The FDA issued a decision of Substantially Equivalent on Jun 21, 2023. The device falls under product code QFG (Alternate Controller Enabled Insulin Infusion Pump), a Class II device regulated under 21 CFR 880.5730. Beta Bionics, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 21, 2023
- Date Received
- May 23, 2023
- Clearance Type
- Special
- 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
- 510(k)
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.