Cleared Traditional

K946249 - BARD JEJUNAL FEEDING/GASTRIC DECOMPRESS...

K946249 is the FDA 510(k) clearance for BARD JEJUNAL FEEDING/GASTRIC DECOMPRESS... by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K946249 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 1995
Decision
353d
Days
Class 2
Risk

K946249 is an FDA 510(k) clearance for the BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on December 11, 1995 after a review of 353 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K946249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1994
Decision Date December 11, 1995
Days to Decision 353 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
223d slower than avg
Panel avg: 130d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 252
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K946249.
P.E.G. PATIENT CARE KIT
K960177 · United States Endoscopy Group, Inc. · Mar 1996
KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT
K954429 · Sherwood Medical Co. · Mar 1996
REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY
K954776 · United States Endoscopy Group, Inc. · Jan 1996
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
K953232 · Hollister, Inc. · Aug 1995
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY
K924306 · United States Endoscopy Group, Inc. · May 1995
FLEXIFLO SIX ENTERAL NUTRITION PUMP SET
K943240 · Abbott Laboratories · Apr 1995