Sterile syringe for single use with/without needle

Q: What is the product code of K210227?

The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.

FDA 510(k) K210227 · Zhejiang Kangkang Medical-Devices Co., Ltd.

Substantially Equivalent

510(k) numberK210227

Submission

Device name: Sterile syringe for single use with/without needle
Applicant: Zhejiang Kangkang Medical-Devices Co., Ltd.
Yuhuan, CN
Received: January 28, 2021
Decision date: September 10, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FMF – Syringe, Piston
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5860
Specialty: General Hospital

Other 510(k)s with product code FMF

510(k)	Device	Applicant	Decision
K262581	GraftGun Universal Graft Delivery System (GDS®)FMF · Special	SurGenTec, LLC	08/26/2026SE
K252184	SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional	Sol-Millennium Medical, Inc.	08/25/2026SE
K253747	Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional	Jiangsu Enjosim Medical Technology Co., Ltd.	08/14/2026SE
K260208	Ultra-Fine SAFETY Insulin SyringeFMF · Traditional	embecta Medical II, LLC	07/13/2026SE
K253110	Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional	Sol-Millennium Medical, Inc.	06/18/2026SE
K260514	Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional	CMT Health PTE., Ltd.	06/12/2026SE
K253112	Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special	Hlb Lifescience Co., Ltd.	05/21/2026SE
K252279	Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional	Chirana T.Injecta,A.S.	04/17/2026SE
K253068	Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional	CMT Health PTE., Ltd.	02/23/2026SE
K253769	Instylla Delivery KitFMF · Special	Instylla, Inc.	12/22/2025SE

More from Instylla, Inc.

510(k)	Device	Decision
K213535	Sterile Safety Hypodermic Needles for Single UseFMI · Traditional	05/13/2022SE
K210229	Sterile Auto-Disable Syringes with/without Needle for Single UseMEG · Traditional	02/15/2022SE
K210232	Sterile Hypodermic Needles for Single UseFMI · Traditional	09/23/2021SE

Questions and answers

When was Sterile syringe for single use with/without needle cleared by the FDA?

Sterile syringe for single use with/without needle (K210227) received a 510(k) decision of Substantially Equivalent on September 10, 2021, 225 days after the submission was received.

What is the product code of K210227?

The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.