# K233287: Vent Vial Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
- Decided: Jul 26, 2024 after 301 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 Vent Vial Adapter is indicated for the transfer and mixing of drugs contained in vials. The device is intended for use by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications. This adapter is suitable for use across all age groups, including neonates, pediatrics, adults, and the elderly.

Source page: https://510kreport.com/device/K233287
Methodology: https://510kreport.com/methodology