Cleared Traditional

K954735 - ENTERALITE

K954735 is an FDA 510(k) clearance for ENTERALITE, 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 182-day FDA review.

K954735 · Zevex Intl., Inc. · General Hospital
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Apr 1996
Decision
182d
Days
Class 2
Risk

K954735 is an FDA 510(k) clearance for the ENTERALITE. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Zevex Intl., Inc. (West Jordan, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 182 days - an extended review 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: 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.

FDA 510(k) Submission Details - K954735

510(k) Number K954735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received October 16, 1995
Decision Date April 15, 1996
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 129d · This submission: 182d
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 33
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K954735.
AMBULATORY ENTERAL NUTRITION PUMP
K003047 · Ross Product Div. Abbott Laboratories · Jun 2001
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
K011587 · Entracon Corp. · Jun 2001
CLEARSTAR ENTERAL NUTRITION PUMP
K981541 · Frantz Medical Development, Ltd. · Aug 1998
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
K946168 · Ivac Corporation · Mar 1996
FLEXIFLO 6.1 ENTERAL NUTRITION PUMP
K951429 · Ross Products · Dec 1995
RATESAVER PLUS
K952671 · Entracare Corp. · Aug 1995
K954735 · ENTERALITE
Download PDF Zevex Intl., Inc.