510(k) K232224
K232224 is an FDA 510(k) premarket notification submitted by Beta Bionics, Inc. for the device "iLet® Dosing Decision Software". The FDA issued a decision of Substantially Equivalent on Sep 22, 2023. The device falls under product code QJI (Interoperable Automated Glycemic Controller), a Class II device regulated under 21 CFR 862.1356. Beta Bionics, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 22, 2023
- Date Received
- Jul 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interoperable Automated Glycemic Controller
- Device Class
- Class II
- Regulation Number
- 862.1356
- Review Panel
- CH
- Submission Type
- 510(k)
An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.