Cleared Traditional

K011340 - LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT

K011340 is an FDA 510(k) clearance for LH 450 ENTERAL FEEDING BAG PUMP SET W/I..., 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.

K011340 · 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

K011340 is an FDA 510(k) clearance for the LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT. 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 - K011340

510(k) Number K011340 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 131d · 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 514
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K011340.
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K012147 · Zevex, Inc. · Nov 2001
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
LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET
K011341 · Lh Medical Products, Inc. · Sep 2001
LH 500 ENTERAL FEEDING GRAVITY BAG SET
K011343 · Lh Medical Products, Inc. · Sep 2001
MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
K012476 · Applied Medical Technology, Inc. · Aug 2001