Class Class II
I.V. Administration Set, I.V. Extension Set (K223645)
Description
I.V. Administration Set, I.V. Extension Set by Bq Plus Medical Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223645
Clearance Date2023-05-18
Clearance TypeTraditional
Product CodeFPA
Regulation Number880.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223645
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. I.V. Administration Set, I.V. Extension Set (K223645) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K111351 | TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECAR... | Us Infusion Dba Truecare Biomedix | 2011 |
Trace the full predicate network for K223645
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.