Class Class II
Vial Adapter (K222718)
Description
Vial Adapter by Hangzhou Qiantang Longyue Biotechnology Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222718
Clearance Date2023-03-10
Clearance TypeTraditional
Product CodeLHI
Regulation Number880.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222718
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. Vial Adapter (K222718) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171796 | Vial Adapter 15mm | Medimop Medical Project , Ltd. | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechno... | 2024 |
| K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechno... | 2024 |
Trace the full predicate network for K222718
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.