Cleared Traditional

K841033 - MILLER-ABBOTT TUBE

K841033 is the FDA 510(k) clearance for MILLER-ABBOTT TUBE by Inmed Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K841033 · Inmed Corp. · Gastroenterology & Urology device

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Apr 1984

Decision

32d

Days

Class 2

Risk

K841033 is an FDA 510(k) clearance for the MILLER-ABBOTT TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Inmed Corp. (Mchenry, US). The FDA issued a Cleared decision on April 13, 1984 after a review of 32 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 Inmed Corp. devices

Submission Details

510(k) Number	K841033 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 12, 1984
Decision Date	April 13, 1984
Days to Decision	32 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

98d faster than avg

Panel avg: 130d · This submission: 32d

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 268

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K841033.

JEJUNOSTOMY SET FOR TUBE FEEDING

K841428 · Burron Medical Products, Inc. · Jul 1984

GORE-TEX CATHETER

K840864 · W.L. Gore & Associates, Inc. · Jun 1984

ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT

K840752 · E-Z-Em, Inc. · May 1984

DEAVER T-DRAIN & CATTEL T-DRAIN

K841034 · Inmed Corp. · Apr 1984

ULTRA BAKER JEJUNOSTOMY TUBE

K841035 · Inmed Corp. · Apr 1984

RECTAL BALLOON CATHETERS

K841036 · Inmed Corp. · Apr 1984

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 K841033

Inmed Corp.

Mchenry, IL · US

Regulatory profile

32 submissions 32 cleared

100% 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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