Safepro Safety Syringe

Q: What is the product code of K022063?

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

FDA 510(k) K022063 · Formosa Medical Devices, Inc.

Substantially Equivalent

510(k) numberK022063

Submission

Device name: Safepro Safety Syringe
Applicant: Formosa Medical Devices, Inc.
Jacksonville, FL, US
Received: June 25, 2002
Decision date: August 29, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code MEG

510(k)	Device	Applicant	Decision
K252098	PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)MEG · Traditional	Methyl Co., Ltd.	02/18/2026SE
K250847	VaporShieldMEG · Traditional	Vault Paragon Group, Inc.	12/12/2025SE
K230287	SaviSafe Safety DeviceMEG · Traditional	Suzhou Savicred Biotechnology Co., Ltd.	11/21/2023SE
K231165	Shina Syringe; Shina Safety SyringeMEG · Traditional	Shina Med Corporation	10/27/2023SE
K231907	Medline Safety Insulin and TB SyringesMEG · Traditional	Medline Industries, LP	10/18/2023SE
K223376	Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…MEG · Abbreviated	Cardinal Health200, LLC	06/21/2023SE
K220114	PowerPAK SyringeMEG · Traditional	Vault Paragon Group, Inc.	01/25/2023SE
K221981	SafeR Syringe and SafeR StingMEG · Traditional	Roncadelle Operations Srl	12/29/2022SE
K222452	Disposable Automatically Retractable Safety Syringes (with detachable needle)MEG · Traditional	Shantou Wealy Medical Instrument Co.,Ltd	11/23/2022SE
K221247	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…MEG · Traditional	Jiangsu Kangbao Medical Equipment Co., Ltd.	11/01/2022SE

More from Jiangsu Kangbao Medical Equipment Co., Ltd.

510(k)	Device	Decision
K050134	Icc Insulin Safepro Safety SyringeMEG · Abbreviated	04/05/2005SE
K031830	Safepro Plus Safety SyringeMEG · Traditional	08/05/2003SE

Questions and answers

When was Safepro Safety Syringe cleared by the FDA?

Safepro Safety Syringe (K022063) received a 510(k) decision of Substantially Equivalent on August 29, 2002, 65 days after the submission was received.

What is the product code of K022063?

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