Cleared Traditional

K172514 - Trak Plus Male Fertility Testing System

K172514 is the FDA 510(k) clearance for Trak Plus Male Fertility Testing System by Sandstone Diagnostics, Inc.. It is a Class 2 Hematology device (product code POV) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K172514 · Sandstone Diagnostics, Inc. · Hematology device
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Nov 2017
Decision
88d
Days
Class 2
Risk

K172514 is an FDA 510(k) clearance for the Trak Plus Male Fertility Testing System. Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Sandstone Diagnostics, Inc. (Livermore, US). The FDA issued a Cleared decision on November 17, 2017 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sandstone Diagnostics, Inc. devices

Submission Details

510(k) Number K172514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2017
Decision Date November 17, 2017
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 113d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POV Semen Analysis Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - POV Semen Analysis Device

All 11
Devices cleared under the same product code (POV) and FDA review panel - the closest regulatory comparables to K172514.
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
K202089 · Bonraybio Co., Ltd. · Oct 2020
SwimCount Sperm Quality Test
K183602 · Motilitycount Aps · Jun 2019
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
K180343 · Bonraybio Co., Ltd. · Nov 2018
SPERMCHECK FERTILITY
K100341 · Princeton BioMeditech Corp. · May 2010
SPERMCHECK VASECTOMY
K073039 · Princeton BioMeditech Corp. · Jan 2008