Cleared Traditional

K850182 - IVAC KEOFEED II POLYURETHANE FEEDING TUBE

K850182 is the FDA 510(k) clearance for IVAC KEOFEED II POLYURETHANE FEEDING TUBE by Y. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K850182 · Y · Gastroenterology & Urology device

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Mar 1985

Decision

60d

Days

Class 2

Risk

K850182 is an FDA 510(k) clearance for the IVAC KEOFEED II POLYURETHANE FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on March 19, 1985 after a review of 60 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 Y devices

Submission Details

510(k) Number	K850182 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 18, 1985
Decision Date	March 19, 1985
Days to Decision	60 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

70d faster than avg

Panel avg: 130d · This submission: 60d

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 283

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K850182.

ENDO-TUBE

K850664 · Biosearch Medical Products, Inc. · Jun 1985

GASTROINTESTINAL TUBE

K851671 · Sheridan Catheter Corp. · Jun 1985

CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO

K851539 · Chesebrough-Pond'S U.S.A. Co. · Jun 1985

KANGAROO NASOGASTRIC FEEDING TUBE

K843567 · Chesebrough-Pond'S U.S.A. Co. · Feb 1985

ENTRON ENTERAL FEEDING BAG

K850134 · Biosearch Medical Products, Inc. · Feb 1985

KANGAROO ACCESS II ENTERAL FEEDING CONTAINER

K844789 · Chesebrough-Pond'S U.S.A. Co. · Jan 1985

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 K850182

San Diego, CA · US

ALBERT P PEDO

Regulatory profile

78 submissions 78 cleared

100% clearance rate · Active in Gastroenterology & Urology

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

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