510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915229Substantially Equivalent

Semen Analysis Kit

CooperSurgical, Inc., Charlottesville VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915229 is the FDA 510(k) clearance record for SEMEN ANALYSIS KIT, a class II device, cleared for Humagen Fertility Diagnostics, Inc. on under FDA product code POV (Semen Analysis Device). FDA's definition for product code POV 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". FDA records list 103 510(k) clearances for COOPERSURGICAL, INC., from to . As of , FDA records show no recalls naming K915229.

Clearance record

Decision date
Received
(1,014 days to decision)
Product code
POV Semen Analysis Device
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Humagen Fertility Diagnostics, Inc. 2345 Hunter'S Way #2, Charlottesville VA
510(k) summary
Statement
Third party review
No

Clearances, product code POV

Trailing 12 months
1 clearance under product code POV in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code POV, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260