510(k) K243114

SQA-iOw Sperm Quality Analyzer by Medical Electronic Systems , Ltd. — Product Code POV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 2, 2025
Date Received: September 30, 2024
Clearance Type: Dual Track
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Semen Analysis Device
Device Class: Class II
Regulation Number: 864.5220
Review Panel: HE
Submission Type

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.

Other clearances by Medical Electronic Systems , Ltd.

K241628 — YO Home Sperm Test (November 29, 2024)
K220828 — SQA-iO Sperm Quality Analyzer (August 7, 2023)
K161493 — YO Home Sperm Test (November 8, 2016)
K063864 — QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS (March 26, 2007)
K021746 — SQA V, SPERM QUALITY ANALYZER (September 20, 2002)
K012352 — SQA, SPERM QUALITY ANALYZER (September 21, 2001)

Other clearances for product code POV

K242830 — LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analy (May 30, 2025)
K242388 — LensHooke X12 PRO Semen Analysis System (May 9, 2025)
K241628 — YO Home Sperm Test (November 29, 2024)
K220828 — SQA-iO Sperm Quality Analyzer (August 7, 2023)
K202089 — LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analy (October 28, 2020)
K183602 — SwimCount Sperm Quality Test (June 27, 2019)
K180343 — LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (November 16, 2018)
K172514 — Trak Plus Male Fertility Testing System (November 17, 2017)
K161493 — YO Home Sperm Test (November 8, 2016)
K153683 — Trak Male Fertility Testing System (May 16, 2016)