Cleared Traditional

K252483 - Enteral Syringe (20ml

K252483 is the FDA 510(k) clearance for Enteral Syringe (20ml by Chirana T.Injecta,A.S.. It is a Class 2 Gastroenterology & Urology device (product code PNR) cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K252483 · Chirana T.Injecta,A.S. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2026
Decision
328d
Days
Class 2
Risk

K252483 is an FDA 510(k) clearance for the Enteral Syringe (20ml, 60ml). Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by Chirana T.Injecta,A.S. (Stará Turá, SK). The FDA issued a Cleared decision on July 1, 2026 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Chirana T.Injecta,A.S. devices

Submission Details

510(k) Number K252483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2025
Decision Date July 01, 2026
Days to Decision 328 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 130d · This submission: 328d
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 24
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K252483.
Profoject Enteral/Oral Feeding Syringe
K253268 · CMT Health PTE., Ltd. · Apr 2026
Profoject™ Enteral Feeding Syringe
K251585 · CMT Health PTE., Ltd. · Jul 2025
Monoject™ Enteral Syringe with ENFit Connector (401SE)
K243652 · Cardinalhealth · Dec 2024
Nutricair Enteral Syringe with ENFit
K231300 · Cair Lgl · Oct 2023
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