FDA 510(k)

Profoject Disposable Syringe, Profoject Disposable Syringe with Needle

K-Number: K252033 · 2025-07-25

Decision Date2025-07-25

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Profoject Disposable Syringe, Profoject Disposable Syringe with Needle is a medical device manufactured by CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2025-07-25 under approval number K252033. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Profoject Disposable Syringe, Profoject Disposable Syringe with Needle?

Profoject Disposable Syringe, Profoject Disposable Syringe with Needle is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by CMT Health PTE., Ltd.. The 510(k) number is K252033.

When was Profoject Disposable Syringe, Profoject Disposable Syringe with Needle approved by the FDA?

Profoject Disposable Syringe, Profoject Disposable Syringe with Needle received FDA 510(k) clearance on 2025-07-25, under approval number K252033.

What company makes Profoject Disposable Syringe, Profoject Disposable Syringe with Needle?

Profoject Disposable Syringe, Profoject Disposable Syringe with Needle is manufactured by CMT Health PTE., Ltd..

What is the FDA product code for Profoject Disposable Syringe, Profoject Disposable Syringe with Needle?

The FDA product code for Profoject Disposable Syringe, Profoject Disposable Syringe with Needle is FMF.

Related Clinical Trials

NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT07498621 Assessment of Maxillary Local Anesthesia Infiltration Using Needle-free Jet vs Conventional Syringe in Tooth Extraction COMPLETED

Other Devices by CMT Health PTE., Ltd.

K252631Profoject Disposable Needle K251585Profoject Enteral Feeding Syringe K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap K253068Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe K252814Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.