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510(k) K153683

Trak Male Fertility Testing System by Sandstone Diagnostics, Inc. — Product Code POV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2016
Date Received
December 22, 2015
Clearance Type
Traditional
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 Sandstone Diagnostics, Inc.

  • K172514 — Trak Plus Male Fertility Testing System (November 17, 2017)

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)
  • K243114 — SQA-iOw Sperm Quality Analyzer (May 2, 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)