FDA 510(k)

Profoject Enteral Feeding Syringe

K-Number: K251585 · 2025-07-18

Decision Date2025-07-18

Product CodePNR

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Profoject Enteral Feeding Syringe is a medical device manufactured by CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2025-07-18 under approval number K251585. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Profoject Enteral Feeding Syringe?

Profoject Enteral Feeding Syringe is a medical device that received FDA 510(k) clearance on 2025-07-18. It is manufactured by CMT Health PTE., Ltd.. The 510(k) number is K251585.

When was Profoject Enteral Feeding Syringe approved by the FDA?

Profoject Enteral Feeding Syringe received FDA 510(k) clearance on 2025-07-18, under approval number K251585.

What company makes Profoject Enteral Feeding Syringe?

Profoject Enteral Feeding Syringe is manufactured by CMT Health PTE., Ltd..

What is the FDA product code for Profoject Enteral Feeding Syringe?

The FDA product code for Profoject Enteral Feeding Syringe is PNR.

Related Clinical Trials

NCT06328894 Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients COMPLETED NCT06328985 Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury Patients COMPLETED NCT01536782 Optimal Tube Feeding Method in Head and Neck Cancer Patients WITHDRAWN

Other Devices by CMT Health PTE., Ltd.

K252631Profoject Disposable Needle K252033Profoject Disposable Syringe, Profoject Disposable Syringe with Needle 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: PNR)

K160855U&U Enteral SyringeU&U Medical Technology Co, Ltd. K162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)Vr Medical Technology K161963Monoject Enteral Syringe with ENFit ConnectorCovidien K161045MonojectCovidien K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)Neomed, Inc. K160419Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien

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.