FDA 510(k)

Profoject Disposable Needle

K-Number: K252631 · 2025-10-16

Decision Date2025-10-16

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Profoject Disposable Needle is a medical device manufactured by CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2025-10-16 under approval number K252631. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Profoject Disposable Needle?

Profoject Disposable Needle is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by CMT Health PTE., Ltd.. The 510(k) number is K252631.

When was Profoject Disposable Needle approved by the FDA?

Profoject Disposable Needle received FDA 510(k) clearance on 2025-10-16, under approval number K252631.

What company makes Profoject Disposable Needle?

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

What is the FDA product code for Profoject Disposable Needle?

The FDA product code for Profoject Disposable Needle is FMI.

Other Devices by CMT Health PTE., Ltd.

K252033Profoject Disposable Syringe, Profoject Disposable Syringe with 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: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), 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.