Cleared Traditional

K052903 - PEDIATRIC FEEDING TUBE

K052903 is an FDA 510(k) clearance for PEDIATRIC FEEDING TUBE, manufactured by Promedic, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K052903 · Promedic, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
26d
Days
Class 2
Risk

K052903 is an FDA 510(k) clearance for the PEDIATRIC FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Promedic, Inc. (Mccordsville, US). The FDA issued a Cleared decision on November 9, 2005 after a review of 26 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Promedic, Inc. devices

FDA 510(k) Submission Details - K052903

510(k) Number K052903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2005
Decision Date November 09, 2005
Days to Decision 26 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
104d faster than avg
Panel avg: 130d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 389
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K052903.
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · C.R. Bard, Inc. · Feb 2007
HOSPIRA ENTERAL FEEDING SET, MODEL 20640
K061432 · Hospira, Inc. · Sep 2006
ENTAKE STANDARD AND SAFETY PEG SYSTEM
K061021 · Conmedcorp · Apr 2006
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K051551 · Olympus Medical Systems Corporation · Jun 2005
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
K043203 · Wilson-Cook Medical, Inc. · May 2005
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02
K043258 · Teleflex Medical · Dec 2004