Cleared Traditional

K891575 - COMPAT ENTERAL FEED PUMP 199235 & 199240

K891575 is an FDA 510(k) clearance for COMPAT ENTERAL FEED PUMP 199235 & 199240, 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 176-day FDA review.

K891575 · Sandoz Nutrition · General Hospital
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Sep 1989
Decision
176d
Days
Class 2
Risk

K891575 is an FDA 510(k) clearance for the COMPAT ENTERAL FEED PUMP 199235 & 199240. 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 September 12, 1989 after a review of 176 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.

View all Sandoz Nutrition devices

FDA 510(k) Submission Details - K891575

510(k) Number K891575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date September 12, 1989
Days to Decision 176 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
47d slower than avg
Panel avg: 129d · This submission: 176d
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.