Class Class II
Rio™ Drug Reconstitution Transfer Device (K243985)
Description
Rio™ Drug Reconstitution Transfer Device by Icu Medical, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243985
Clearance Date2025-01-22
Clearance TypeTraditional
Product CodeLHI
Regulation Number880.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243985
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. Rio™ Drug Reconstitution Transfer Device (K243985) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192154 | Rio Vial-to-Bag Drug Reconstitution Device | Icu Medical | 2020 |
Trace the full predicate network for K243985
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.