Cleared Traditional

K051480 - ENTERAL FEEDING TUBE

K051480 is an FDA 510(k) clearance for ENTERAL FEEDING TUBE, manufactured by Biosearch Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code BSS cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K051480 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Oct 2005
Decision
131d
Days
Class 2
Risk

K051480 is an FDA 510(k) clearance for the ENTERAL FEEDING TUBE. Classified as Tube, Nasogastric (product code BSS), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Branchburg, US). The FDA issued a Cleared decision on October 12, 2005 after a review of 131 days - within the typical 510(k) review window.

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 Biosearch Medical Products, Inc. devices

FDA 510(k) Submission Details - K051480

510(k) Number K051480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2005
Decision Date October 12, 2005
Days to Decision 131 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 131d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSS Device Classification - Class 2, Special Controls

Product Code BSS Tube, Nasogastric
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 - BSS Tube, Nasogastric

All 8
Devices cleared under the same product code (BSS) and FDA review panel - the closest regulatory comparables to K051480.
TurboSEAL Nasogastric Aspiration Tube
K142483 · Turboseal, L.P. · Dec 2014
MOSS TUBES, INC. NASAL TUBE - MARK IV
K984629 · Moss Tubes, Inc. · Mar 1999
ASPISAFE GASTRIC TUBE
K961711 · B.Braun Medical, Inc. · Jun 1997
GASTRIC, CATHETER, IRRIGATION & ASPIRATION
K933596 · Polamedco, Inc. · Feb 1995
ARGYLE POLYURETHANE SALEM SUMP TUBE
K910479 · Sherwood Medical Co. · Apr 1991
WILTEK NASAL BILIARY DRAINAGE SET
K894870 · Wiltek Medical, Inc. · Dec 1989