# K021993: Shanchuan Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Shangdong Zibo Shanchuan Medical Instruments Co.
- Decided: Jun 3, 2003 after 350 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: 2 generations back to K771205 (1977). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980181: Terumo Disposable Hypodermc Syringe, Terumo Medical Corp. (1998) Summary page 3.
- K941657: BD Micro Fine, Ultra Fine, and Allergy Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

## Most influential descendants
- K052551: Devon Standard Syringe, Hypodermic Needle and Insulin Syringe (2005), 0 descendants of its own

## Indications for use
The SHANCHUAN Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle. The SHANCHUAN Insulin Syringe is design for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needlehub assembly. The needle shield is colored orange. The syringe fluid path is sterile, non-toxic, non-pyrogen and single use, disposable.

Source page: https://510kreport.com/device/K021993
Methodology: https://510kreport.com/methodology