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FDA 510(k)

Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle

K-Number: K252033 · 2025-07-25

ApplicantCMT Health PTE., Ltd.
Decision Date2025-07-25
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle is the device name listed in this FDA 510(k) record. The listed applicant is CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2025-07-25 under 510(k) 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. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K252033.

When did Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle?

The FDA 510(k) record lists CMT Health PTE., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing CMT Health PTE., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261829Profoject™ Dual-Safety Pen NeedlesK260739Profoject™ Pen Needles (Model A; Model B)K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleK260855Profoject™ Safety Pen NeedlesK253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes CapK253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

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Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

Official Source

View on FDA Database →

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

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