Cleared Traditional

SQA-iO Sperm Quality Analyzer

K220828 · Medical Electronic Systems , Ltd. · Hematology

Aug 2023

Decision

503d

Days

Class 2

Risk

About This 510(k) Submission

K220828 is an FDA 510(k) clearance for the SQA-iO 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 August 7, 2023, 503 days after receiving the submission on March 22, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K220828 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2022
Decision Date	August 07, 2023
Days to Decision	503 days
Submission Type	Traditional
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.