Device class
Class II
Regulation 880.5725
Total clearances
4
2020-02-21 → 2024-11-27
Definition
What is Infusion Pump, Drug Specific, Pharmacy-Filled
A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.
Classification details
Medical specialty
General Hospital
Regulation number
880.5725
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 |
| E1520 |
HCPCS
|
Heparin infusion pump for hemodialysis ✓ CMS-verified description |
High
|
Heparin infusion pump supply; standard HCPCS for drug-specific pharmacy-filled pump systems |
| E1521 |
HCPCS
|
— |
Medium
|
Infusion pump accessory/supply depending on specific drug and system configuration |
Pulse
Most recent 510(k) clearances