Cleared Traditional

K901835 - LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)

K901835 is an FDA 510(k) clearance for LAKE N/G FEEDING TUBE (WITH Y PORT CONN..., manufactured by Lake Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K901835 · Lake Medical Products, Inc. · Gastroenterology & Urology device
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Sep 1990
Decision
139d
Days
Class 2
Risk

K901835 is an FDA 510(k) clearance for the LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR). Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Lake Medical Products, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 5, 1990 after a review of 139 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 Lake Medical Products, Inc. devices

FDA 510(k) Submission Details - K901835

510(k) Number K901835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1990
Decision Date September 05, 1990
Days to Decision 139 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
8d slower than avg
Panel avg: 131d · This submission: 139d
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 483
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K901835.
600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA
K895329 · Delmed, Inc. · Oct 1990
ENTERAL PUMP SET W/ENTERA-FLO SPIKE
K895650 · Delmed, Inc. · Oct 1990
MIC ANAL INCONTINENCE TUBE
K902684 · Medical Innovations Corp. · Sep 1990
DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE
K900324 · Biosearch Medical Products, Inc. · Aug 1990
DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH
K900563 · Biosearch Medical Products, Inc. · Aug 1990
BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING
K900590 · Biosearch Medical Products, Inc. · Aug 1990