Tests Required for Syringes — FDA 510(k)

FDA 510(k) clearance for syringes requires biocompatibility, dimensional, leak, and sterility testing. LMG guides syringe manufacturers through the complete required test program.

Class II DeviceISO 10993Sterility TestingSince 2009

Required Tests for Syringe 510(k) Submission

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.

Frequently Asked Questions

Common questions about this FDA 510(k) for syringes.

What biocompatibility tests are required?

ISO 10993 biocompatibility evaluation based on the nature and duration of patient contact — typically cytotoxicity, sensitization, and irritation at minimum.

Does LMG help identify required tests?

Yes. LMG reviews your device type and intended use and provides a complete test requirement list before 510(k) submission preparation begins.

How long does testing take before 510(k) submission?

Testing timelines vary by test type.