Cleared Traditional

K841289 - RECTAL IRRIGATION TUBE

K841289 is an FDA 510(k) clearance for RECTAL IRRIGATION TUBE, manufactured by Hdc Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K841289 · Hdc Corp. · Gastroenterology & Urology device
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Jul 1984
Decision
100d
Days
Class 2
Risk

K841289 is an FDA 510(k) clearance for the RECTAL IRRIGATION TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Hdc Corp. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hdc Corp. devices

FDA 510(k) Submission Details - K841289

510(k) Number K841289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1984
Decision Date July 06, 1984
Days to Decision 100 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
30d faster than avg
Panel avg: 130d · This submission: 100d
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 344
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K841289.
MIC GASTROSTOMY TUBE
K842076 · Medical Innovations Corp. · Aug 1984
IVAC KEOFEED HYDROPHILIC FEEDING TUBE
K842589 · Y · Aug 1984
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
MILLER-ABBOTT TUBE
K841033 · Inmed Corp. · Apr 1984