Cleared Traditional

K040196 - KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS

K040196 is an FDA 510(k) clearance for KENDALL EPUMP ENTERAL FEEDING PUMP AND ..., manufactured by Tyco Healthcare/Kendall. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K040196 · Tyco Healthcare/Kendall · General Hospital
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May 2004
Decision
97d
Days
Class 2
Risk

K040196 is an FDA 510(k) clearance for the KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Tyco Healthcare/Kendall (Mansfield, US). The FDA issued a Cleared decision on May 5, 2004 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tyco Healthcare/Kendall devices

FDA 510(k) Submission Details - K040196

510(k) Number K040196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2004
Decision Date May 05, 2004
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZH Device Classification - Class 2, Special Controls

Product Code LZH Pump, Infusion, Enteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - LZH Pump, Infusion, Enteral

All 26
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K040196.
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET
K131154 · Zevex, Inc. · Feb 2014
MEDI-SIS SYRINGE INFUSION SYSTEM
K111381 · Acacia, Inc. · Jan 2012
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K060316 · Fresenius Kabi Deutschland GmbH · Jun 2006
ENTERALITE INFINITY ENTERAL FEEDING PUMP
K031199 · Zevex Intl., Inc. · Jul 2003
ROSS EMBRACE ENTERAL PUMP
K031407 · Ross Product Div. Abbott Laboratories · May 2003
ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
K011868 · Debio Tech SA · Sep 2001