Class Class II
SperSort™ Sperm Sorting Chip (IPG02) (K241626)
Description
SperSort™ Sperm Sorting Chip (IPG02) by Ipreg Incorporation, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241626
Clearance Date2025-02-20
Clearance TypeTraditional
Product CodeMQK
Regulation Number884.6160
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241626
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. SperSort™ Sperm Sorting Chip (IPG02) (K241626) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separ... | Dxnow, Inc. | 2018 |
Trace the full predicate network for K241626
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.