FDA 510(k) for Syringes
Syringes are a Class II Medical Device requiring FDA 510(k) clearance before marketing in the USA. LMG provides expert 510(k) consulting for syringe manufacturers worldwide.
510(k) Requirements for Syringes
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.
Regulation Number | Syringe Code | Syringe Class | Syringe Type |
870.1650 | MAV | Class 2 | Syringe, Balloon Inflation |
870.1650 | PTM | Class 2 | 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.
FDA 510(k) for Syringes — FAQs
What FDA product code applies to syringes?
Are prefillable syringes regulated differently?
Do safety syringe manufacturers need 510(k)?
Need a Syringes 510(k) Consultant?
LMG provides expert 510(k) consulting for syringes manufacturers — from predicate device selection through clearance.
Contact for 510(k) 510(k) Overview