Device class
Class II
Regulation 862.1358
Total clearances
5
2022-01-27 → 2025-11-18
Definition
What is Continuous Glucose Monitor Informed Insulin Dose Calculator
A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.1358
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 |
| 95251 |
CPT
|
— |
Medium
|
Continuous glucose monitoring code; software calculator may be bundled or separately billed depending on implementation |
| E0607 |
HCPCS
|
Home blood glucose monitor ✓ CMS-verified description |
Medium
|
HCPCS for continuous glucose monitor receiver/monitor device component |
Pulse
Most recent 510(k) clearances