Cleared Traditional

Profoject? Enteral Feeding Syringe

K251585 · CMT Health PTE., Ltd. · Gastroenterology & Urology
Jul 2025
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K251585 is an FDA 510(k) clearance for the Profoject? Enteral Feeding Syringe, a Enteral Syringes With Enteral Specific Connectors (Class II — Special Controls, product code PNR), submitted by CMT Health PTE., Ltd. (Singapore, SG). The FDA issued a Cleared decision on July 18, 2025, 56 days after receiving the submission on May 23, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K251585 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2025
Decision Date July 18, 2025
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code PNR — Enteral Syringes With Enteral Specific Connectors
Device Class Class II — 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.

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