# K022159: Piston Syringe & Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: International Medsurg Connection
- Decided: Nov 7, 2002 after 128 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Piston Syringes: named in the summary without a submission number
- (no number) Nipro needles: named in the summary without a submission number

## Most influential descendants
- K102969: Imc Piston Syringes (2010), 2 descendants of its own
- K111841: Shifeng Disposable Syringe with or Without Needle (2012), 1 descendant of its own
- K133493: Single Use Sterile Syringe with Needle (2014), 0 descendants of its own

## Indications for use
This device is intended for inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger

Source page: https://510kreport.com/device/K022159
Methodology: https://510kreport.com/methodology