# K102328: Blunt Fill Needle and Blunt Plastic Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Weigao Group Medical Polymer Co., Ltd.
- Decided: May 13, 2011 after 269 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: 2 generations back to K920422 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974006: Becton Dickinson Twinpak, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 3.

## Most influential descendants
- K120420: Sterile Blunt for Single Use (2012), 0 descendants of its own

## Indications for use
The blunts include two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle is used in conjunction with a syringe to penetrate the vial/amnpoules stopper intended for injection or aspiration of fluid. The blunt plastic cannula is used in conjunction with a syringe to access the pie-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.

Source page: https://510kreport.com/device/K102328
Methodology: https://510kreport.com/methodology