Cleared Traditional

K945964 - KANGAROO 524 ENTERAL FEEDING PUMP AND A...

K945964 is the FDA 510(k) clearance for KANGAROO 524 ENTERAL FEEDING PUMP AND A... by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code LZH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K945964 · Sherwood Medical Co. · General Hospital
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Mar 1995
Decision
90d
Days
Class 2
Risk

K945964 is an FDA 510(k) clearance for the KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Joseph, US). The FDA issued a Cleared decision on March 7, 1995 after a review of 90 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.

View all Sherwood Medical Co. devices

Submission Details

510(k) Number K945964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 07, 1994
Decision Date March 07, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 11
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K945964.
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
K153074 · Covidien · Jul 2016
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K143263 · Covidien · May 2015
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · Covidien · Dec 2014
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