# K052551: Devon Standard Syringe, Hypodermic Needle and Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Devon Safety Products, Inc.
- Decided: Sep 30, 2005 after 14 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: 3 generations back to K771205 (1977). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 1.
- K941657: BD Micro Fine, Ultra Fine, and Allergy Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.
- K021993: Shanchuan Syringe, Shangdong Zibo Shanchuan Medical Instruments Co. (2003) Summary page 1.
- K013293: Nipro Hypodermic Needle, Nipro Medical Corp. (2001) Summary page 1.

## Indications for use
This device is intended for injection of fluids into, or withdrawing fluids from, parts of the body below the surface of the skin. Syringe with plunger for general medical uses. The Insulin syringes are intended for insulin injection.

Source page: https://510kreport.com/device/K052551
Methodology: https://510kreport.com/methodology