Cleared Traditional

K051206 - Y2K2 ENTERNAL TUBE FLUID FILTER

K051206 is an FDA 510(k) clearance for Y2K2 ENTERNAL TUBE FLUID FILTER, manufactured by Moss Medical Products. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K051206 · Moss Medical Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
175d
Days
Class 2
Risk

K051206 is an FDA 510(k) clearance for the Y2K2 ENTERNAL TUBE FLUID FILTER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Moss Medical Products (West Sand Lake, US). The FDA issued a Cleared decision on November 2, 2005 after a review of 175 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 Moss Medical Products devices

FDA 510(k) Submission Details - K051206

510(k) Number K051206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2005
Decision Date November 02, 2005
Days to Decision 175 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 130d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K051206.
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