Cleared Traditional

K901458 - NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP

K901458 is an FDA 510(k) clearance for NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP, manufactured by Clinical Systems, Inc.. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K901458 · Clinical Systems, Inc. · General Hospital
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Jun 1990
Decision
86d
Days
Class 2
Risk

K901458 is an FDA 510(k) clearance for the NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Clinical Systems, Inc. (Great Neck, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clinical Systems, Inc. devices

FDA 510(k) Submission Details - K901458

510(k) Number K901458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1990
Decision Date June 22, 1990
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 21
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K901458.
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
COMPAT ENTERAL FEED PUMP 199235 & 199240
K891575 · Sandoz Nutrition · Sep 1989