510(k) K234055
K234055 is an FDA 510(k) premarket notification submitted by Deka Research and Development for the device "DEKA Loop". The FDA issued a decision of Substantially Equivalent on March 13, 2024. The device falls under product code QJI (Interoperable Automated Glycemic Controller), a Class II device regulated under 21 CFR 862.1356. Deka Research and Development has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2024
- Date Received
- December 22, 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
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.