Cleared Traditional

YO Home Sperm Test

K161493 · Medical Electronic Systems , Ltd. · Hematology

Nov 2016

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K161493 is an FDA 510(k) clearance for the YO Home Sperm Test, a Semen Analysis Device (Class II — Special Controls, product code POV), submitted by Medical Electronic Systems , Ltd. (Caesarea Ind. Park, IL). The FDA issued a Cleared decision on November 8, 2016, 160 days after receiving the submission on June 1, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K161493 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2016
Decision Date	November 08, 2016
Days to Decision	160 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.