Cleared Traditional

K040957 - NOA III ENTERAL NUTRITION PUMP

K040957 is an FDA 510(k) clearance for NOA III ENTERAL NUTRITION PUMP, manufactured by Caesarea Medical Electronics , Ltd.. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K040957 · Caesarea Medical Electronics , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
38d
Days
Class 2
Risk

K040957 is an FDA 510(k) clearance for the NOA III ENTERAL NUTRITION PUMP. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Caesarea Medical Electronics , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on May 21, 2004 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040957

510(k) Number K040957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2004
Decision Date May 21, 2004
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
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 32
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K040957.
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
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
K040196 · Tyco Healthcare/Kendall · May 2004
ENTERALITE INFINITY ENTERAL FEEDING PUMP
K031199 · Zevex Intl., Inc. · Jul 2003
ROSS EMBRACE ENTERAL PUMP
K031407 · Ross Product Div. Abbott Laboratories · May 2003
K040957 · NOA III ENTERAL NUTRITION PUMP
Download PDF Caesarea Medical Elec…