Class Class II
FLOWRUNNER Aspiration System (K251488)
Description
FLOWRUNNER Aspiration System by Expanse Medical, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251488
Clearance Date2025-07-14
Clearance TypeSpecial
Product CodeQEZ
Regulation Number870.5150
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251488
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. FLOWRUNNER Aspiration System (K251488) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K234073 | ICE Aspiration System | Expanse Medical, Inc. | 2024 |
Trace the full predicate network for K251488
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.