510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012352Substantially Equivalent

Sqa, Sperm Quality Analyzer

Medical Electronic Systems Ltd., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012352 is the FDA 510(k) clearance record for SQA, SPERM QUALITY ANALYZER, a class II device, cleared for Medical Electronic Systems, LLC 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 7 510(k) clearances for Medical Electronic Systems, LLC, from to . As of , FDA records show no recalls naming K012352.

Clearance record

Decision date
Received
(58 days to decision)
Product code
POV Semen Analysis Device
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Medical Electronic Systems, LLC 6363 Greenwich Dr., San Diego CA
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 October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code POV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260