Class Class II
FloPatch FP120 (K223843)
Description
FloPatch FP120 by Flosonics Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223843
Clearance Date2023-05-03
Clearance TypeTraditional
Product CodeDPW
Regulation Number870.2100
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223843
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. FloPatch FP120 (K223843) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222242 | FloPatch FP120 | Flosonics Medical | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251114 | FloPatch FP120 | Flosonics Medical | 2025 |
Trace the full predicate network for K223843
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.