# K233284: Vial Adapter with Filter

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
- Decided: May 1, 2024 after 215 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963583 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222718: Vial Adapter, Hangzhou Qiantang Longyue Biotechnology Co., Ltd. (2023) Summary page 5.

## Indications for use
The Vial adapter with filter is intended for use by Healthcare Professionals for the transfer and mixing of drugs contained in vials within clinical, hospital, or healthcare environments.

Source page: https://510kreport.com/device/K233284
Methodology: https://510kreport.com/methodology