# K090929: Sterile Hypodermic Syringe and Needle for Single Use, Sterile Insuling Syringe for Single Use with Fixed Needle

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Double Dove Industrial Co., Ltd.
- Decided: Jun 12, 2009 after 71 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K931367 (1993). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980987: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 2.
- K071630: Terumo 31G Thinpro Insulin Syringe, Terumo Medical Corp. (2007) Summary page 2.
- K070440: BD Hypoint Needle, Becton, Dickinson & CO (2007) Summary page 2.

## Most influential descendants
- K110697: Tiger Syringes and Needles (2011), 0 descendants of its own

## Indications for use
The Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical. The sterile Insulin Syringe for single use with fixed needle is a device is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin, and for the injection of insulin into parts of the body below the surface skin. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Source page: https://510kreport.com/device/K090929
Methodology: https://510kreport.com/methodology