Cleared Traditional

K800918 - MODIFIED FEEDING JEJUNOSTOMY TUBE

K800918 is an FDA 510(k) clearance for MODIFIED FEEDING JEJUNOSTOMY TUBE, manufactured by Mitchell V. Kaminski, Jr., M.D.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K800918 · Mitchell V. Kaminski, Jr., M.D. · Gastroenterology & Urology device
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Jul 1980
Decision
97d
Days
Class 2
Risk

K800918 is an FDA 510(k) clearance for the MODIFIED FEEDING JEJUNOSTOMY TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Mitchell V. Kaminski, Jr., M.D. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 97 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.

FDA 510(k) Submission Details - K800918

510(k) Number K800918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1980
Decision Date July 28, 1980
Days to Decision 97 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
34d faster than avg
Panel avg: 131d · This submission: 97d
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 528
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K800918.
OESOPHAGEAL THERAPY KIT
K810392 · Keymed, Inc. · Mar 1981
ARGYLE SALEM SUMP TUBE
K810156 · Sherwood Medical Co. · Mar 1981
FEEDING TUBES IN SILICONE 5,6,8&10 SIZES
K802585 · The Healthcare Group Laboratories, Inc. · Oct 1980
ENTRI NASOGASTRIC FEEDING TUBE
K801498 · Biosearch Medical Products, Inc. · Jul 1980
NASO-GARD NASOGASTRIC TUBE HOLDER
K801511 · Howmedica Corp. · Jul 1980
ENTERIC FEEDING TUBE W/SEGM. FLEX. WT.
K801558 · Biosearch Medical Products, Inc. · Jul 1980