Cleared Traditional

SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION (K940555) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 9
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K940555.
AMSure Enteral Feeding Pump
K220230 · Amsino International, Inc. · Nov 2022
PUGGLE Enteral Feeding Pump and Feeding Set
K200051 · Amsino International, Inc. · Sep 2020
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964 · Sherwood Medical Co. · Mar 1995
FLO-GARD 2100 - 2M8281M
K923066 · Baxter Healthcare Corp · May 1993
FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
K913958 · Abbott Laboratories · Feb 1992
KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE
K913413 · Sherwood Medical Co. · Nov 1991