FDA 510 K Submission - Syringe

FDA classifies syringes as Class 1 and Class 2 medical devices; most class 1 syringes are exempted from 510(k) requirements. Class 2 syringes require FDA 510(k) clearance to market in the USA.

FDA Classification for Class II Syringe

Regulation Number

Syringe Code

Syringe Class

Syringe Type

870.1650

MAV

Class 2

Syringe, Balloon Inflation

870.1650

PTM

Class 2
510(K) Exempt

Syringe, Balloon Inflation

872.6770

EJI

Class 2

Cartridge Syringe

876.5820

FIH

Class 2

Pump, Infusion Or Syringe

876.5980

PNR

Class 2

Enteral Syringes

880.5860

MZM

Class 2

Fibrin Sealant Preparation Device

870.1670

DQF

Class 2

Actuator, Syringe

870.1650

DXT

Class 2

Angiographic Injector And Syringe

870.1650

IZQ

Class 2

Injector, Contrast Medium, Automatic

870.1650

NKP

Class 2

Injector, Contrast Medium, Automatic, Reprocessed

870.1650

NKT

Class 2

Reprocessed Angiographic Injector And Syringe

880.5860

FMF

Class 2

Piston Syringe

880.6920

KZH

Class 2

Syringe Needle Introducer

880.5860

MEG

Class 2

Syringe, Antistick

880.5860

NKN

Class 2

Reprocessed Piston Syringe

880.5860

NSC

Class 2

Injector, Pen

880.5860

PQX

Class 2

Epinephrine Syringe

880.5860

PUR

Class 2

Vacuum Syringe

880.5860

QBL

Class 2

Piston Syringe Lever

880.5860

QDM

Class 2

Midazolam Syringe

880.5860

QEH

Class 2

Piston Syringe With Neuraxial Connector

880.5860

QLF

Class 2

On-Body Injector

880.5860

QLY

Class 2

Ophthalmic Syringe

880.5860

QNQ

Class 2

Low Dead Space Piston Syringe

880.5860

QOG

Class 2

Injection Data Capture Device

This is not a complete list of FDA classifications for syringes; please visit the FDA website for updated classification information.

LMG Provides assistance to syringe manufacturers in FDA registration, 510(k) clearance, device listing, and US FDA Agent requirements.

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

  • Prepare 510 K notification
  • Submission of 510 K notification
  • FDA Agent service for 510 K submission
  • Guidance in test requirements
  • Register your establishment with FDA
  • List your syringe with FDA.

Test Requirements for syringe for US FDA 510(K) Submission

US FDA 510(K) Submission Requirements

FDA 510(K) Consultant