Cleared Traditional

K844789 - KANGAROO ACCESS II ENTERAL FEEDING CONTAINER

K844789 is an FDA 510(k) clearance for KANGAROO ACCESS II ENTERAL FEEDING CONT..., manufactured by Chesebrough-Pond'S U.S.A. Co.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K844789 · Chesebrough-Pond'S U.S.A. Co. · Gastroenterology & Urology device
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Jan 1985
Decision
23d
Days
Class 2
Risk

K844789 is an FDA 510(k) clearance for the KANGAROO ACCESS II ENTERAL FEEDING CONTAINER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Chesebrough-Pond'S U.S.A. Co. (Trumbull, US). The FDA issued a Cleared decision on January 2, 1985 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology 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 Chesebrough-Pond'S U.S.A. Co. devices

FDA 510(k) Submission Details - K844789

510(k) Number K844789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1984
Decision Date January 02, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 131d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 406
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K844789.
ENTRON ENTERAL FEEDING BAG
K850134 · Biosearch Medical Products, Inc. · Feb 1985
ENTERNAL FEEDING TUBE-POLYURETHANE EF504
K844175 · Exco, Inc. · Jan 1985
ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403
K844203 · Exco, Inc. · Jan 1985
FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI
K844174 · Exco, Inc. · Dec 1984
BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR
K844222 · Biosearch Medical Products, Inc. · Dec 1984
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP
K843305 · C.R. Bard, Inc. · Oct 1984