Device class
Class II
Regulation 876.5880
Total clearances
5
2020-04-24 → 2025-01-24
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.5880
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 |
| E1632 |
HCPCS
|
Wearable artificial kidney, each ✓ CMS-verified description |
Medium
|
HCPCS code for kidney perfusion supplies and organ preservation systems |
Pulse
Most recent 510(k) clearances