Class Class II
SOZO Pro (K230530)
Description
SOZO Pro by ImpediMed Limited, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230530
Clearance Date2023-05-04
Clearance TypeSpecial
Product CodeOBH
Regulation Number870.2770
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230530
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. SOZO Pro (K230530) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | 2020 |
| K180126 | SOZO | ImpediMed Limited | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232089 | SOZO Pro | ImpediMed Limited | 2023 |
Trace the full predicate network for K230530
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.