Cleared Dual Track

SQA-iOw Sperm Quality Analyzer

K243114 · Medical Electronic Systems , Ltd. · Hematology

May 2025

Decision

214d

Days

Class 2

Risk

About This 510(k) Submission

K243114 is an FDA 510(k) clearance for the SQA-iOw Sperm Quality Analyzer, a Semen Analysis Device (Class II — Special Controls, product code POV), submitted by Medical Electronic Systems , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on May 2, 2025, 214 days after receiving the submission on September 30, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K243114 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	May 02, 2025
Days to Decision	214 days
Submission Type	Dual Track
Review Panel	Hematology (HE)
Summary	Summary PDF

Device Classification

Product Code	POV — Semen Analysis Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.5220
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.