# K103587: Disposable Bllod Collection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Weihai Hongyu Medical Devices Co., Ltd.
- Decided: Apr 6, 2011 after 120 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K950159 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073127: Blood Collection Needle, Model 20G 21G 22G, Shandong Weigao Group Medical Polymer Co., Ltd. (2007) Summary page 2.

## Indications for use
Disposable Blood Collection Needles is designed for use in the daily blood collection routine when delegated by a qualified practitioner.

Source page: https://510kreport.com/device/K103587
Methodology: https://510kreport.com/methodology