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FDA 510(k)

Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap

K-Number: K253268 · 2026-04-08

ApplicantCMT Health PTE., Ltd.
Decision Date2026-04-08
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap 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 2026-04-08 under 510(k) number K253268. 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/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap?

Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K253268.

When did Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap receive FDA 510(k) clearance?

Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap received FDA 510(k) clearance on 2026-04-08, under 510(k) number K253268.

Who is the listed applicant for Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap?

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/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap?

The FDA product code for Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap 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 NeedlesK253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeK252814Profoject™ 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

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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.K251585Profoject™ Enteral Feeding SyringeCMT 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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