# POV: Semen Analysis Device

- Device class: 2; regulation: 21 CFR 864.5220; FDA's rule: 510(k) required
- FDA decisions: 28
- 510(k) review time 2021–2025: median 253 days (middle half 214–270)
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 1
- 2016: 2
- 2017: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2023: 1
- 2024: 1
- 2025: 3
- 2026: 1

## Most-cited predicates
- K021746: Sqa V, Sperm Quality Analyzer (2002), cited by 5
- K041039: Fertell Male Fertility Test (2004), cited by 3
- K011679: Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility (2001), cited by 3
- K180343: LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (2018), cited by 2
- K100341: Spermcheck Fertility (2010), cited by 2
- K202089: LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer (2020), cited by 2
- K915229: Semen Analysis Kit (1994), cited by 2
- K073039: Spermcheck Vasectomy (2008), cited by 1
- K153683: Trak Male Fertility Testing System (2016), cited by 1
- K161493: YO Home Sperm Test (2016), cited by 1

Source page: https://510kreport.com/product-code/POV
Data by year (CSV): https://510kreport.com/product-code/POV.csv