# K021746: Sqa V, Sperm Quality Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medical Electronic Systems, LLC
- Decided: Sep 20, 2002 after 115 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.
9 later devices descend from it; 5 cite it directly.
0 of 10 devices 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.

## Most influential descendants
- K180343: LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (2018), 4 descendants of its own
- K202089: LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer (2020), 2 descendants of its own
- K161493: YO Home Sperm Test (2016), 1 descendant of its own
- K252228: Seaman Pro/Seaman (2026), 0 descendants of its own
- K242830: LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (2025), 0 descendants of its own

## Indications for use
The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis. The SQA V provides direct and calculated measurements for: total sperm concentration (TSC, niillions/ml) percent motility (%MOT) and % progressive motility (%!?MOT) % normal morphology (%MORPH) motile sperm concentration (MSC, millions/mL) and progressive MSC (PMSC) functional sperm concentration (FSC, millions/mL)

Source page: https://510kreport.com/device/K021746
Methodology: https://510kreport.com/methodology