Class Class II
Multi4 System (K250522)
Description
Multi4 System by Multi4 Medical AB, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250522
Clearance Date2025-06-27
Clearance TypeTraditional
Product CodeFAS
Regulation Number876.4300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250522
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. Multi4 System (K250522) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192498 | Single Use Injector | Olympus Medical Systems Corp. | 2020 |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxi... | Corinth Medtech, Inc. | 2019 |
Trace the full predicate network for K250522
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.