POVClass II

Semen Analysis Device

21 CFR 864.5220 / Hematology

POV is the FDA product code for Semen Analysis Device, a class II device type, regulated under 21 CFR 864.5220. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 28 510(k) clearances under this code, the most recent dated 2026-04-09, and 2 recalls.

Classification record

Product code: POV
Device name: Semen Analysis Device
FDA 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.
Regulation: 21 CFR 864.5220
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 28
Ingested recalls: 2

Clearances, product code POV

By decision year

28 clearances under product code POV with a decision year between 1989 and 2026, 2025 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code POV by decision year
Year	Clearances
1989	2
1994	1
1998	1
1999	1
2001	2
2002	2
2003	2
2004	1
2007	2
2008	1
2010	1
2016	2
2017	1
2018	1
2019	1
2020	1
2023	1
2024	1
2025	3
2026	1

Applicants with the most clearances

Product code POV

Applicants holding the most 510(k) clearances under product code POV
Applicant	Clearances
Medical Electronic Systems Ltd.	7
Bonraybio Co., Ltd.	4
Embryotech Laboratories, Inc.	2
Hamilton Thorne Research	2
Princeton BioMeditech Corp.	2
Sandstone Diagnostics, Inc.	2
Biocoat, Inc.	1
Bioshaf, Ltd.	1
Checkcells, Inc.	1
Dyn-Bioshaf (2006), Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order