# Semen Analysis Device
> **Product code: POV** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5220
## Classification
- **FDA Product Code:** POV
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.5220
- **Review panel:** HE
- **Medical specialty:** Hematology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

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.

## Market data
- **Cleared 510(k) submissions:** 28
- **Registered establishments:** 13
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=POV)
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