Cleared Traditional

K945964 - KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS

K945964 is an FDA 510(k) clearance for KANGAROO 524 ENTERAL FEEDING PUMP AND A..., 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 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

FDA 510(k) Submission Details - K945964

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.

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 19
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K945964.
CLEARSTAR ENTERAL NUTRITION PUMP
K981541 · Frantz Medical Development, Ltd. · Aug 1998
ENTERALITE
K954735 · Zevex Intl., Inc. · Apr 1996
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
K946168 · Ivac Corporation · Mar 1996
SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION
K940555 · Sandoz Nutrition · Feb 1995
SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP
K940556 · Sandoz Nutrition · Nov 1994
FLO-GARD 2100 - 2M8281M
K923066 · Baxter Healthcare Corp · May 1993