# K220828: SQA-iO Sperm Quality Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medical Electronic Systems, Ltd.
- Decided: Aug 7, 2023 after 503 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 4.

## Indications for use
The SQA-iO Sperm Quality Analyzer is an automated point-of-care in vitro use only medical device for semen analysis performed by healthcare professionals (trained lab technicians). The SQA-iO does not provide a comprehensive evaluation of a male’s fertility status. The SQA-iO provides direct and calculated quantitative measurements for the following parameters: Directly measured parameters: • Sperm Concentration, M/mL • Motile Sperm Concentration (MSC), M/mL • Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapid and Slow PMSC, millions/mL) • Normal Forms (Normal Morphology), % Calculated parameters: • Total Motility (PR + NP), % • Progressive Motility (PR), % (combines Rapidly and Slowly Progressive Motility, %) • Non-Progressive Motility (NP), % • Immotile (IM), % • Functional Sperm Concentration (FSC), millions/mL

Source page: https://510kreport.com/device/K220828
Methodology: https://510kreport.com/methodology