510(k) K253701
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2026
- Date Received
- November 24, 2025
- 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
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.