Class Class II
SafeBreak® Vascular (K223486)
Description
SafeBreak® Vascular by Lineus Medical, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223486
Clearance Date2023-05-19
Clearance TypeTraditional
Product CodeQOI
Regulation Number880.5220
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223486
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. SafeBreak® Vascular (K223486) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222791 | SafeBreak Vascular | Lineus Medical, LLC | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231957 | SafeBreak® Vascular | Lineus Medical | 2023 |
Trace the full predicate network for K223486
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.