Device class
Class II
Regulation 864.5220
Total clearances
7
2020-10-28 → 2026-04-09
Definition
What is Semen Analysis Device
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.
Classification details
Medical specialty
Hematology
Regulation number
864.5220
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 |
| 89310 |
CPT
|
— |
High
|
Semen analysis; presence and/or motility of sperm including Huhner test |
| 89320 |
CPT
|
— |
High
|
Semen analysis; volume, count, motility, morphology |
Pulse
Most recent 510(k) clearances