Cleared Traditional

K940555 - SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION

K940555 is an FDA 510(k) clearance for SANDOZ NUTRITION COMPAT ENTERAL FEED PU..., manufactured by Sandoz Nutrition. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K940555 · Sandoz Nutrition · General Hospital
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Feb 1995
Decision
359d
Days
Class 2
Risk

K940555 is an FDA 510(k) clearance for the SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Sandoz Nutrition (Minneapolis, US). The FDA issued a Cleared decision on February 1, 1995 after a review of 359 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Sandoz Nutrition devices

FDA 510(k) Submission Details - K940555

510(k) Number K940555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received February 07, 1994
Decision Date February 01, 1995
Days to Decision 359 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
230d slower than avg
Panel avg: 129d · This submission: 359d
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 20
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K940555.
ENTERALITE
K954735 · Zevex Intl., Inc. · Apr 1996
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
K946168 · Ivac Corporation · Mar 1996
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964 · Sherwood Medical Co. · Mar 1995
SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP
K940556 · Sandoz Nutrition · Nov 1994
FLO-GARD 2100 - 2M8281M
K923066 · Baxter Healthcare Corp · May 1993
FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
K913958 · Abbott Laboratories · Feb 1992