# K243114: SQA-iOw Sperm Quality Analyzer

- Pathway: 510(k) (Dual Track)
- Applicant: Medical Electronic Systems, Ltd.
- Decided: May 2, 2025 after 214 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
Longest line of descent: 1 generation back to K021746 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021746: Sqa V, Sperm Quality Analyzer, Medical Electronic Systems, LLC (2002) Summary page 5.

## Indications for use
The SQA-iOw Sperm Quality Analyzer is an automated analyzer intended for in-vitro diagnostic use to determine the following parameters in semen: Measured parameters: • Sperm Concentration/ Total Sperm Concentration, millions/mL • Motile Sperm Concentration (MSC), millions/mL • Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly Progressive Motile Sperm Concentration, millions/mL) • Normal Forms (% Normal Morphology), % Derived parameters: • Total Motility / Total Motile (PR + NP), % • Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %) • Non-Progressive (NP), % • Immotile (IM), % The SQA-iOw is intended for CLIA Waived settings. The SQA-iOw does not provide a comprehensive evaluation of a male’s fertility status and is intended for in vitro use only.

Source page: https://510kreport.com/device/K243114
Methodology: https://510kreport.com/methodology