Cleared Traditional

K841986 - PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAG...

K841986 is the FDA 510(k) clearance for PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAG... by Protomed Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K841986 · Protomed Corp. · Gastroenterology & Urology device
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Sep 1984
Decision
118d
Days
Class 2
Risk

K841986 is an FDA 510(k) clearance for the PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Protomed Corp. (Wayne, US). The FDA issued a Cleared decision on September 10, 1984 after a review of 118 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 Protomed Corp. devices

Submission Details

510(k) Number K841986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1984
Decision Date September 10, 1984
Days to Decision 118 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
12d faster than avg
Panel avg: 130d · This submission: 118d
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 284
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K841986.
BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR
K844222 · Biosearch Medical Products, Inc. · Dec 1984
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP
K843305 · C.R. Bard, Inc. · Oct 1984
GAUDERER GASTROSTOMY BUTTON
K843392 · American V. Mueller · Oct 1984
IVAC KEOFEED HYDROPHILIC FEEDING TUBE
K842589 · Y · Aug 1984
JEJUNOSTOMY SET FOR TUBE FEEDING
K841428 · Burron Medical Products, Inc. · Jul 1984
RECTAL IRRIGATION TUBE
K841289 · Hdc Corp. · Jul 1984