DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution (K250459)
Description
DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution by Technoflex Sas., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250459
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. DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution (K250459) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 10... | Gilero, LLC | 2021 |
Trace the full predicate network for K250459
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.