# K233277: Filter Needle for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
- Decided: May 10, 2024 after 224 days
- Product code: FPB (Filter, Infusion Line)
- 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: 1 generation back to K801343 (1980). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801343: B-D Filter Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1980) Summary page 5.

## Indications for use
This product is intended for the aspiration, filtration and preparation ofmedical fluid, not including injection.

Source page: https://510kreport.com/device/K233277
Methodology: https://510kreport.com/methodology