Cleared Traditional

K946168 - IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS

K946168 is an FDA 510(k) clearance for IVAC ENTERAL ADMIN. SETS, manufactured by Ivac Corporation. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 458-day FDA review.

K946168 · Ivac Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
458d
Days
Class 2
Risk

K946168 is an FDA 510(k) clearance for the IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Ivac Corporation (San Diego, US). The FDA issued a Cleared decision on March 21, 1996 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Ivac Corporation devices

FDA 510(k) Submission Details - K946168

510(k) Number K946168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1994
Decision Date March 21, 1996
Days to Decision 458 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
329d slower than avg
Panel avg: 129d · This submission: 458d
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 18
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K946168.
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
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964 · Sherwood Medical Co. · Mar 1995
SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION
K940555 · Sandoz Nutrition · Feb 1995
SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP
K940556 · Sandoz Nutrition · Nov 1994