# K120420: Sterile Blunt for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Double Dove Industrial Co., Ltd.
- Decided: Oct 18, 2012 after 251 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: 3 generations back to K920422 (1992). 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)
- K102328: Blunt Fill Needle and Blunt Plastic Cannula, Shandong Weigao Group Medical Polymer Co., Ltd. (2011) Summary page 3.

## Indications for use
Sterile Blunt for Single Use includes 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/ampoules stopper for injection or aspiration of fluid. The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on IV System intended for injection or aspiration of fluid.

Source page: https://510kreport.com/device/K120420
Methodology: https://510kreport.com/methodology