SwimCount Sperm Quality Test— 510(k) K183602

Substantially Equivalent

Motilitycount Aps

FDA 510(k) clearance K183602 for SwimCount Sperm Quality Test, Substantially Equivalent on 2019-06-27. Applicant: Motilitycount Aps. Device class: 2.

Clearance details

Applicant: Motilitycount Aps
Product code: Code POV
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2018-12-26
Decision date: 2019-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valby, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code POV

K252228 — Seaman Pro/Seaman2026-04-09
K242830 — LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer2025-05-30
K242388 — LensHooke X12 PRO Semen Analysis System2025-05-09
K243114 — SQA-iOw Sperm Quality Analyzer2025-05-02
K241628 — YO Home Sperm Test2024-11-29

More clearances from Motilitycount Aps

K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)2025-01-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.