Device class
Class II
Regulation 862.1356
Total clearances
23
2020-06-16 → 2026-09-16
Definition
What is Interoperable Automated Glycemic Controller
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.
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.1356
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 95250 |
CPT
|
— |
High
|
Continuous glucose monitoring; glucose monitoring with automated controller |
| 95251 |
CPT
|
— |
High
|
Continuous glucose monitoring system; automated glycemic control with CGM integration |
| E0607 |
HCPCS
|
Home blood glucose monitor ✓ CMS-verified description |
High
|
Insulin infusion pump; durable medical equipment code for interoperable automated delivery |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-16 |
K261896 |
CamDiab
|
iOS CamAPS FX |
| 2026-09-11 |
K262763 |
Beta Bionics, Inc.
|
iLet Dosing Decision Software |
| 2026-07-09 |
K261962 |
Medtronic MiniMed
|
SmartGuard Technology; Predictive Low Glucose Technology |
| 2026-06-29 |
K261461 |
Insulet Corporation
|
Omnipod 6 algorithm |
| 2026-04-24 |
K260429 |
Tandem Diabetes Care, Inc.
|
Control-IQ+ technology |
| 2026-02-03 |
K253701 |
Medtronic Minimed
|
SmartGuard Technology; Predictive Low Glucose Technology |
| 2026-01-14 |
K253585 |
Medtronic Minimed, Inc.
|
SmartGuard technology; Predictive Low Glucose technology |
| 2025-12-19 |
K251152 |
Diabeloop
|
DBLG2 |
| 2025-12-03 |
K251779 |
Insulet Corporation
|
Omnipod 5 algorithm |
| 2025-08-29 |
K251217 |
Medtronic Minimed, Inc.
|
SmartGuard technology; Predictive Low Glucose technology |
| 2025-05-21 |
K250798 |
Tandem Diabetes Care, Inc.
|
Control-IQ+ technology |
| 2025-02-24 |
K243823 |
Tandem Diabetes Care, Inc.
|
Control-IQ+ technology |
| 2024-08-26 |
K241777 |
Insulet Corporation
|
SmartAdjust Technology |
| 2024-05-29 |
K232741 |
Insulet Corporation
|
SmartAdjust(TM) technology |
| 2024-05-23 |
K232603 |
Camdiab , Ltd.
|
CamAPS FX |
| 2024-03-13 |
K234055 |
Deka Research and Development
|
DEKA Loop |
| 2023-11-03 |
K232382 |
Tandem Diabetes Care, Inc.
|
Control-IQ Technology |
| 2023-09-22 |
K232224 |
Beta Bionics, Inc.
|
iLet® Dosing Decision Software |
| 2023-05-19 |
K220916 |
Beta Bionics, Inc.
|
iLet® Dosing Decision Software |
| 2023-01-23 |
K203689 |
Tidepool Project
|
Tidepool Loop |
| 2022-08-19 |
K220394 |
Insulet Corporation
|
SmartAdjust(TM) technology |
| 2022-01-27 |
K203774 |
Insulet Corporation
|
SmartAdjust technology |
| 2020-06-16 |
K200467 |
Tandem Diabetes Care, Inc.
|
Control-IQ Technology |