Cleared Traditional

K011343 - LH 500 ENTERAL FEEDING GRAVITY BAG SET

K011343 is an FDA 510(k) clearance for LH 500 ENTERAL FEEDING GRAVITY BAG SET, manufactured by Lh Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K011343 · Lh Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
142d
Days
Class 2
Risk

K011343 is an FDA 510(k) clearance for the LH 500 ENTERAL FEEDING GRAVITY BAG SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Lh Medical Products, Inc. (San Dimas, US). The FDA issued a Cleared decision on September 21, 2001 after a review of 142 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 Lh Medical Products, Inc. devices

FDA 510(k) Submission Details - K011343

510(k) Number K011343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2001
Decision Date September 21, 2001
Days to Decision 142 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
12d slower than avg
Panel avg: 130d · This submission: 142d
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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K011343.
RUSCH CANTOR TUBE
K010798 · Rusch Intl. · Feb 2002
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · C.R. Bard, Inc. · Oct 2001
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH
K013162 · Medcomp · Oct 2001
TRIP TONOMETRY CATHETER, 14F
K993296 · Datex-Ohmeda, Inc. · Dec 1999
NUTRISAFE EXTENSION TUBE
K991918 · Vygon Corp. · Oct 1999
BARD BALLOON INFLATION SYSTEM
K991375 · C.R. Bard, Inc. · Sep 1999