Cleared Traditional

SwimCount Sperm Quality Test

K183602 · Motilitycount Aps · Hematology

Jun 2019

Decision

183d

Days

Class 2

Risk

About This 510(k) Submission

K183602 is an FDA 510(k) clearance for the SwimCount Sperm Quality Test, a Semen Analysis Device (Class II — Special Controls, product code POV), submitted by Motilitycount Aps (Valby, DK). The FDA issued a Cleared decision on June 27, 2019, 183 days after receiving the submission on December 26, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K183602 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2018
Decision Date	June 27, 2019
Days to Decision	183 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.