# K022495: Gettig Disposable Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Gettig Pharmaceutical Instrument Co.
- Decided: Oct 8, 2002 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: 2 generations back to K771205 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941562: 1ML Luer-Lok Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.
- K980181: Terumo Disposable Hypodermc Syringe, Terumo Medical Corp. (1998) Summary page 1.

## Indications for use
The Gettig Disposable Syringe, with or without a hypodermic single lumen needle, is used for injecting fluids into or withdrawing fluids from the body. The syringe is designed for manual use.

Source page: https://510kreport.com/device/K022495
Methodology: https://510kreport.com/methodology