Cleared Traditional

K810854 - KANGAROO NASOGASTRIC FEEDING TUBE

K810854 is the FDA 510(k) clearance for KANGAROO NASOGASTRIC FEEDING TUBE by Chesebrough-Pond'S U.S.A. Co.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K810854 · Chesebrough-Pond'S U.S.A. Co. · Gastroenterology & Urology device

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Apr 1981

Decision

18d

Days

Class 2

Risk

K810854 is an FDA 510(k) clearance for the KANGAROO NASOGASTRIC FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Chesebrough-Pond'S U.S.A. Co. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 18 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

Submission Details

510(k) Number	K810854 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 30, 1981
Decision Date	April 17, 1981
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

112d faster than avg

Panel avg: 130d · This submission: 18d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 206

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K810854.

ENTRI ENTERNAL FEEDING SET

K811683 · Biosearch Medical Products, Inc. · Jul 1981

ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT

K810979 · Arrow Intl., Inc. · Jun 1981

ENTERNAL PUMP SET W/INTEGRAL CONTAINER

K810996 · Abbott Laboratories · Apr 1981

ARGYLE SALEM SUMP TUBE

K810156 · Sherwood Medical Co. · Mar 1981

ENTRI NASOGASTRIC FEEDING TUBE

K801498 · Biosearch Medical Products, Inc. · Jul 1980

NASO-GARD NASOGASTRIC TUBE HOLDER

K801511 · Howmedica Corp. · Jul 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K810854

Chesebrough-Pond'S U.S.A. Co.

Mchenry, IL · US

Regulatory profile

33 submissions 30 cleared

91% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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