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FDA 510(k)

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

K-Number: K241348 · 2025-01-31

ApplicantMotilitycount Aps
Decision Date2025-01-31
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) is the device name listed in this FDA 510(k) record. The listed applicant is Motilitycount Aps. It received FDA 510(k) clearance on 2025-01-31 under 510(k) number K241348. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)?

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) is a medical device that received FDA 510(k) clearance on 2025-01-31. The listed applicant is Motilitycount Aps. The 510(k) number is K241348.

When did SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) receive FDA 510(k) clearance?

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) received FDA 510(k) clearance on 2025-01-31, under 510(k) number K241348.

Who is the listed applicant for SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)?

The FDA 510(k) record lists Motilitycount Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)?

The FDA product code for SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) is MQK.

Other records listing Motilitycount Aps as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183602SwimCount Sperm Quality Test

Related Devices (Code: MQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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