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FDA 510(k)

SwimCount Sperm Quality Test

K-Number: K183602 · 2019-06-27

ApplicantMotilitycount Aps
Decision Date2019-06-27
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SwimCount Sperm Quality Test is a medical device manufactured by Motilitycount Aps. It received FDA 510(k) clearance on 2019-06-27 under approval number K183602. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SwimCount Sperm Quality Test?

SwimCount Sperm Quality Test is a medical device that received FDA 510(k) clearance on 2019-06-27. It is manufactured by Motilitycount Aps. The 510(k) number is K183602.

When was SwimCount Sperm Quality Test approved by the FDA?

SwimCount Sperm Quality Test received FDA 510(k) clearance on 2019-06-27, under approval number K183602.

What company makes SwimCount Sperm Quality Test?

SwimCount Sperm Quality Test is manufactured by Motilitycount Aps.

What is the FDA product code for SwimCount Sperm Quality Test?

The FDA product code for SwimCount Sperm Quality Test is POV.

Related Clinical Trials

NCT07605182 Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age NOT_YET_RECRUITING NCT06238570 Validation of Donor Oocytes Semi-automated Vitrification RECRUITING NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Motilitycount Aps

K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

Related Devices (Code: POV)

K161493YO Home Sperm TestMedical Electronic Systems , Ltd. K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. K172514Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc. K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerBonraybio Co., Ltd. K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd. K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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