Cleared Traditional

K012352 - SQA, SPERM QUALITY ANALYZER

K012352 is an FDA 510(k) clearance for SQA, manufactured by Medical Electronic Systems, LLC. The device is a Class 2 Hematology device with product code POV cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K012352 · Medical Electronic Systems, LLC · Hematology device
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Sep 2001
Decision
58d
Days
Class 2
Risk

K012352 is an FDA 510(k) clearance for the SQA, SPERM QUALITY ANALYZER. Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Medical Electronic Systems, LLC (San Diego, US). The FDA issued a Cleared decision on September 21, 2001 after a review of 58 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.

FDA 510(k) Submission Details - K012352

510(k) Number K012352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2001
Decision Date September 21, 2001
Days to Decision 58 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 113d · This submission: 58d
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.

Regulatory Peers - POV Semen Analysis Device

All 27
Devices cleared under the same product code (POV) and FDA review panel - the closest regulatory comparables to K012352.
GENERAL SEMEN ANALYSIS (GSA) KIT
K024337 · Bioshaf , Ltd. · Jul 2003
SQA V, SPERM QUALITY ANALYZER
K021746 · Medical Electronic Systems, LLC · Sep 2002
AUTOMARQER
K012805 · Hamilton Thorne Research · Mar 2002
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
K011679 · Embryotech Laboratories, Inc. · Aug 2001
AUTOMARQER
K990184 · Hamilton Thorne Research · Mar 1999
FERTILMARQ TEST KIT
K983473 · Embryotech Laboratories, Inc. · Dec 1998
K012352 · SQA, SPERM QUALITY ANALYZER
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