Cleared Traditional

KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS (K040196) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 33
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K040196.
Luminoah FLOW™ Enteral Nutrition System
K253558 · Luminoah · Apr 2026
Vesco Q™ Enteral Feeding Pump
K232205 · Vesco Medical, LLC · Oct 2023
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
K221603 · Cardinal Health, LLC · Dec 2022
AMSure Enteral Feeding Pump
K220230 · Amsino International, Inc. · Nov 2022
PUGGLE Enteral Feeding Pump and Feeding Set
K200051 · Amsino International, Inc. · Sep 2020
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964 · Sherwood Medical Co. · Mar 1995