Cleared Traditional

K913413 - KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE

K913413 is an FDA 510(k) clearance for KANGAROO PET(TM) ENTERAL FEED PUMP/CHAR..., manufactured by Sherwood Medical Co.. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K913413 · Sherwood Medical Co. · General Hospital
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Nov 1991
Decision
121d
Days
Class 2
Risk

K913413 is an FDA 510(k) clearance for the KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on November 29, 1991 after a review of 121 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K913413

510(k) Number K913413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1991
Decision Date November 29, 1991
Days to Decision 121 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 129d · This submission: 121d
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 33
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K913413.
FLO-GARD 2100 - 2M8281M
K923066 · Baxter Healthcare Corp · May 1993
FRENTA II+ ENTERAL FEEDING PUMP
K914216 · Fresenius Pharma · Mar 1992
FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
K913958 · Abbott Laboratories · Feb 1992
NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP
K901458 · Clinical Systems, Inc. · Jun 1990
COMPAT ENTERAL FEED PUMP 199235 & 199240
K891575 · Sandoz Nutrition · Sep 1989
FLEXIFLO COMPANION ENTERAL NUTRITION PUMP
K873119 · Frantz Medical Development, Ltd. · Nov 1987
K913413 · KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE
Download PDF Sherwood Medical Co.