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FDA 510(k)

Profoject™ Enteral Feeding Syringe

K-Number: K251585 · 2025-07-18

ApplicantCMT Health PTE., Ltd.
Decision Date2025-07-18
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Profoject™ Enteral Feeding Syringe 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 2025-07-18 under 510(k) 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. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K251585.

When did Profoject™ Enteral Feeding Syringe receive FDA 510(k) clearance?

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

Who is the listed applicant for Profoject™ Enteral Feeding Syringe?

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™ Enteral Feeding Syringe?

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

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

View all 10 devices →

Related Devices (Code: PNR)

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.

K252483Enteral Syringe (20ml, 60ml)Chirana T.Injecta,A.S.K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes CapCMT Health PTE., Ltd.K243652Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)CardinalhealthK231300Nutricair Enteral Syringe with ENFitCair LglK222772Oral/Enteral Syringe with ENFit connectorAnhui Tiankang Medical Technology Co., Ltd.K211661ENFit enteral syringes (NUTRIFIT)Pentaferte Italia S.R.L.

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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