Device class
Class II
Regulation 862.1358
Total clearances
3
2020-08-28 → 2023-10-03
Definition
What is Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors.
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 |
| 95981 |
CPT
|
— |
Medium
|
Insulin pump initiation and management; therapy parameter adjustment |
| 99457 |
CPT
|
— |
Medium
|
Chronic condition remote monitoring; insulin pump therapy adjustment support |
Pulse
Most recent 510(k) clearances