Cleared Traditional

K031199 - ENTERALITE INFINITY ENTERAL FEEDING PUMP

K031199 is an FDA 510(k) clearance for ENTERALITE INFINITY ENTERAL FEEDING PUMP, manufactured by Zevex Intl., Inc.. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K031199 · Zevex Intl., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
86d
Days
Class 2
Risk

K031199 is an FDA 510(k) clearance for the ENTERALITE INFINITY ENTERAL FEEDING PUMP. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Zevex Intl., Inc. (San Diego, US). The FDA issued a Cleared decision on July 9, 2003 after a review of 86 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.

View all Zevex Intl., Inc. devices

FDA 510(k) Submission Details - K031199

510(k) Number K031199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2003
Decision Date July 09, 2003
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 19
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K031199.
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K143263 · Covidien · May 2015
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · Covidien · Dec 2014
MEDI-SIS SYRINGE INFUSION SYSTEM
K111381 · Acacia, Inc. · Jan 2012
CLEARSTAR ENTERAL NUTRITION PUMP
K981541 · Frantz Medical Development, Ltd. · Aug 1998
ENTERALITE
K954735 · Zevex Intl., Inc. · Apr 1996
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
K946168 · Ivac Corporation · Mar 1996