Cleared Traditional

FRENTA II+ ENTERAL FEEDING PUMP (K914216) - FDA 510(k) Clearance

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

K914216 · Fresenius Pharma · General Hospital
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Mar 1992
Decision
181d
Days
Class 2
Risk

K914216 is an FDA 510(k) clearance for the FRENTA II+ ENTERAL FEEDING PUMP. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Fresenius Pharma (New Brunswick, US). The FDA issued a Cleared decision on March 18, 1992 after a review of 181 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 Fresenius Pharma devices

Submission Details

510(k) Number K914216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1991
Decision Date March 18, 1992
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 129d · This submission: 181d
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 K914216.
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