Class Class II
VitalFlow Console (K250199)
Description
VitalFlow Console by Medtronic, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250199
Clearance Date2025-05-20
Clearance TypeTraditional
Product CodeQNR
Regulation Number870.4100
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250199
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. VitalFlow Console (K250199) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230364 | VitalFlow Console | Michigan Critical Care Consultants,... | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K140717 | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URIN... | Siemens Healthcare Diagnostics | 2014 |
Trace the full predicate network for K250199
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.