Cleared Traditional

K253268 - Profoject Enteral/Oral Feeding Syringe (FDA 510(k) Clearance)

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

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253268 · CMT Health PTE., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
191d
Days
Class 2
Risk

K253268 is an FDA 510(k) clearance for the Profoject Enteral/Oral Feeding Syringe. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by CMT Health PTE., Ltd. (Singapore, SG). The FDA issued a Cleared decision on April 8, 2026 after a review of 191 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all CMT Health PTE., Ltd. devices

Submission Details

510(k) Number K253268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date April 08, 2026
Days to Decision 191 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 130d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNR Enteral Syringes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition Delivers Nutrition, Medication, Or Hydration Orally Or To A Gastrointestinal Tube Or Extension Set Using Aami/cn3(ps):2014 Compliant Connectors.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PNR Enteral Syringes With Enteral Specific Connectors

All 33
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K253268.
Profoject™ Enteral Feeding Syringe
K251585 · CMT Health PTE., Ltd. · Jul 2025
Monoject™ Enteral Syringe with ENFit Connector (401SE)
K243652 · Cardinalhealth · Dec 2024
Oral/Enteral Syringe with ENFit connector
K222772 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2023
Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector
K222155 · Jiangsu Caina Medical Co.,Ltd · Sep 2022
Enteral Pump Syringe
K211593 · Jiangsu Caina Medical Co.,Ltd · Sep 2021