# K012352: Sqa, Sperm Quality Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medical Electronic Systems, LLC
- Decided: Sep 21, 2001 after 58 days
- Product code: POV (Semen Analysis Device)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SQA is a point-of-care, easy-to-use, electro-optical device for semen analysis. The SQA provides calculated measurements for: total cell concentration (millions/mL) percent (%) motility % normal morphology motile sperm concentration (MSC), (millions/mL) functional sperm concentration (FSC), (millions/mL) sperm motility index (SMI)

Source page: https://510kreport.com/device/K012352
Methodology: https://510kreport.com/methodology