# K141359: Hard Pack Syringe

- Pathway: 510(k) (Special)
- Applicant: Jiangyin Caina Technology Co., Ltd.
- Decided: Jul 25, 2014 after 63 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: 1 generation back to K113091 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113091: Syringes, With or without Needles, Jiangyin Caina Technology Co., Ltd. (2011) Summary page 4.

## Indications for use
Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body. Needles am intended to be used with a legally marketed syringe intended to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K141359
Methodology: https://510kreport.com/methodology