Class Class II
SQA-iOw Sperm Quality Analyzer (K243114)
Description
SQA-iOw Sperm Quality Analyzer by Medical Electronic Systems , Ltd., an FDA 510(k) cleared hematology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243114
Clearance Date2025-05-02
Clearance TypeDual Track
Product CodePOV
Regulation Number864.5220
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243114
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SQA-iOw Sperm Quality Analyzer (K243114) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K021746 | SQA V, SPERM QUALITY ANALYZER | Medical Electronic Systems, LLC | 2002 |
Trace the full predicate network for K243114
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.