Device class
Class II
Regulation 880.5725
Total clearances
7
2022-03-01 → 2026-04-02
Definition
What is Infusion Safety Management Software
Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.
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 |
| E1352 |
HCPCS
|
Oxygen accessory, flow regulator capable of positive inspiratory pressure ✓ CMS-verified description |
Medium
|
Infusion pump, programmable, stationary or portable; software bundled with pump billing |
| 99607 |
CPT
|
— |
Low
|
Software services; may be reported separately under pharmacy/clinical decision support in future |
Pulse
Most recent 510(k) clearances