Cleared Traditional

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

K241348 · Motilitycount Aps · Obstetrics & Gynecology

Jan 2025

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K241348 is an FDA 510(k) clearance for the SwimCount? Harvester (1 mL); SwimCount? Harvester (3 mL), a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Motilitycount Aps (Valby, DK). The FDA issued a Cleared decision on January 31, 2025, 263 days after receiving the submission on May 13, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.

Submission Details

510(k) Number	K241348 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2024
Decision Date	January 31, 2025
Days to Decision	263 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF