Safepro Plus Safety Syringe

FDA 510(k) K031830 · Formosa Medical Devices, Inc.

Substantially Equivalent

510(k) numberK031830

Submission

Device name
Safepro Plus Safety Syringe
Applicant
Formosa Medical Devices, Inc.
Jacksonville, FL, US
Received
June 13, 2003
Decision date
August 5, 2003
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)DeviceApplicantDecision
K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)MEG · Traditional Methyl Co., Ltd.02/18/2026SE
K250847VaporShieldMEG · Traditional Vault Paragon Group, Inc.12/12/2025SE
K230287SaviSafe Safety DeviceMEG · Traditional Suzhou Savicred Biotechnology Co., Ltd.11/21/2023SE
K231165Shina Syringe; Shina Safety SyringeMEG · Traditional Shina Med Corporation10/27/2023SE
K231907Medline Safety Insulin and TB SyringesMEG · Traditional Medline Industries, LP10/18/2023SE
K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…MEG · Abbreviated Cardinal Health200, LLC06/21/2023SE
K220114PowerPAK SyringeMEG · Traditional Vault Paragon Group, Inc.01/25/2023SE
K221981SafeR Syringe and SafeR StingMEG · Traditional Roncadelle Operations Srl12/29/2022SE
K222452Disposable Automatically Retractable Safety Syringes (with detachable needle)MEG · Traditional Shantou Wealy Medical Instrument Co.,Ltd11/23/2022SE
K221247Sterile 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)DeviceDecision
K050134Icc Insulin Safepro Safety SyringeMEG · Abbreviated 04/05/2005SE
K022063Safepro Safety SyringeMEG · Traditional 08/29/2002SE

Questions and answers

When was Safepro Plus Safety Syringe cleared by the FDA?

Safepro Plus Safety Syringe (K031830) received a 510(k) decision of Substantially Equivalent on August 5, 2003, 53 days after the submission was received.

What is the product code of K031830?

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