Cleared Traditional

K915229 - SEMEN ANALYSIS KIT

K915229 is an FDA 510(k) clearance for SEMEN ANALYSIS KIT, manufactured by Humagen Fertility Diagnostics, Inc.. The device is a Class 2 Hematology device with product code POV cleared through the Traditional 510(k) pathway after a 1014-day FDA review.

K915229 · Humagen Fertility Diagnostics, Inc. · Hematology device
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Aug 1994
Decision
1014d
Days
Class 2
Risk

K915229 is an FDA 510(k) clearance for the SEMEN ANALYSIS KIT. Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Humagen Fertility Diagnostics, Inc. (Charlottesville, US). The FDA issued a Cleared decision on August 30, 1994 after a review of 1014 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Humagen Fertility Diagnostics, Inc. devices

FDA 510(k) Submission Details - K915229

510(k) Number K915229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1991
Decision Date August 30, 1994
Days to Decision 1014 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
901d slower than avg
Panel avg: 113d · This submission: 1014d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

POV Device Classification - Class 2, Special Controls

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.