# K260301: Vial Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
- Decided: Jun 5, 2026 after 126 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 K925401 (1993). 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)
- K201469: Mini Spike Plus 6/8R, B.Braun Medical, Inc. (2020) Summary page 5.

## Indications for use
Vial adapters are intended to be used for aspiration from single-dose container and multi-dose containers. Model VA-722000, VA-722050, VA-722051, VA-742000, VA-742050, VA-742051 can be matched with a 20mm vial closure diameter and a 22mm vial body diameter (6R/8R), model VA-721000, VA-721050, VA-741000, VA-741050 can be matched with a 13mm vial closure diameter and a 16mm vial body diameter (2R/3R/4R) and model VA-720001, VA-720051, VA-740001, VA-740051 can be matched with any size containers.

Source page: https://510kreport.com/device/K260301
Methodology: https://510kreport.com/methodology