Cleared Traditional

K841035 - ULTRA BAKER JEJUNOSTOMY TUBE

K841035 is an FDA 510(k) clearance for ULTRA BAKER JEJUNOSTOMY TUBE, manufactured by Inmed Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K841035 · Inmed Corp. · Gastroenterology & Urology device
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Apr 1984
Decision
32d
Days
Class 2
Risk

K841035 is an FDA 510(k) clearance for the ULTRA BAKER JEJUNOSTOMY 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

FDA 510(k) Submission Details - K841035

510(k) Number K841035 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
99d faster than avg
Panel avg: 131d · This submission: 32d
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 470
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K841035.
WEIGHTED FEEDING TUBE W/PRE-INSERTED
K841014 · Ethox Corp. · May 1984
MILLER-ABBOTT TUBE
K841033 · Inmed Corp. · Apr 1984
DEAVER T-DRAIN & CATTEL T-DRAIN
K841034 · Inmed Corp. · Apr 1984
RECTAL BALLOON CATHETERS
K841036 · Inmed Corp. · Apr 1984
BLAKEMORE TUBE
K841038 · Inmed Corp. · Apr 1984
CANTOR TUBE
K841039 · Inmed Corp. · Apr 1984