# K110697: Tiger Syringes and Needles

- Pathway: 510(k) (Traditional)
- Applicant: Tiger Medical Products, Ltd.
- Decided: Jul 14, 2011 after 122 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: 4 generations back to K931367 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
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.
- K090929: Sterile Hypodermic Syringe and Needle for Single Use, Sterile Insuling Syringe for Single Use with Fixed Needle, Shanghai Double Dove Industrial Co., Ltd. (2009) Summary page 2.
- K070440: BD Hypoint Needle, Becton, Dickinson & CO (2007) Summary page 2.

## Indications for use
The Syringe with or without needle is intended for dispensing/administering fluids, and collecting/ sampling of fluid in medical practice. The insulin syringe (U-lOO) with fixed needle is a device intended for medical purposes for the manual aspiration of U-lO0 insulin, and for the injection of U-lOO insulin into parts of the body below the surface skin. The proposed device of Insulin Syringe (U-100) with fixed needle is available in 0.3m1, .Sml, and l in volume. The 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/K110697
Methodology: https://510kreport.com/methodology