Sterile Hypodermic Needles for Single Use

Q: What is the product code of K210232?

The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.

FDA 510(k) K210232 · Zhejiang Kangkang Medical-Devices Co., Ltd.

Substantially Equivalent

510(k) numberK210232

Submission

Device name: Sterile Hypodermic Needles for Single Use
Applicant: Zhejiang Kangkang Medical-Devices Co., Ltd.
Yuhuan, CN
Received: January 28, 2021
Decision date: September 23, 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: FMI – Needle, Hypodermic, Single Lumen
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5570
Specialty: General Hospital

Other 510(k)s with product code FMI

510(k)	Device	Applicant	Decision
K261719	Promisemed X-Safety Pen NeedleFMI · Special	Promisemed Hangzhou Meditech Co., Ltd.	08/25/2026SE
K262427	Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special	Hh Global Technology, Inc.	08/10/2026SE
K260933	Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	08/07/2026SE
K261829	Profoject Dual-Safety Pen NeedlesFMI · Traditional	CMT Health PTE., Ltd.	07/29/2026SE
K260739	Profoject Pen Needles (Model A; Model B)FMI · Traditional	CMT Health PTE., Ltd.	07/15/2026SE
K260855	Profoject Safety Pen NeedlesFMI · Traditional	CMT Health PTE., Ltd.	06/10/2026SE
K254273	Verisafe Safety Sterile Needles (SSN)FMI · Special	Promisemed Hangzhou Meditech Co., Ltd.	04/16/2026SE
K252908	Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special	Sandstone Medical (Suzhou), Inc.	03/25/2026SE
K253047	PressoneFMI · Traditional	Nipro Medical Corporation	03/24/2026SE
K253622	Safety Pen NeedleFMI · Traditional	Ningbo Medsun Medical Co., Ltd.	03/18/2026SE

More from Ningbo Medsun Medical Co., Ltd.

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
K210227	Sterile syringe for single use with/without needleFMF · Traditional	09/10/2021SE

Questions and answers

When was Sterile Hypodermic Needles for Single Use cleared by the FDA?

Sterile Hypodermic Needles for Single Use (K210232) received a 510(k) decision of Substantially Equivalent on September 23, 2021, 238 days after the submission was received.

What is the product code of K210232?

The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.