Cleared Traditional

K990365 - GASTRIC LAVAGE VALVE

K990365 is an FDA 510(k) clearance for GASTRIC LAVAGE VALVE, manufactured by T-Med Vac Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 537-day FDA review.

K990365 · T-Med Vac Corporation · Gastroenterology & Urology device
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Jul 2000
Decision
537d
Days
Class 2
Risk

K990365 is an FDA 510(k) clearance for the GASTRIC LAVAGE VALVE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by T-Med Vac Corporation (Racine, US). The FDA issued a Cleared decision on July 26, 2000 after a review of 537 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all T-Med Vac Corporation devices

FDA 510(k) Submission Details - K990365

510(k) Number K990365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1999
Decision Date July 26, 2000
Days to Decision 537 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
407d slower than avg
Panel avg: 130d · This submission: 537d
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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K990365.
RUSCH CANTOR TUBE
K010798 · Rusch Intl. · Feb 2002
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · C.R. Bard, Inc. · Oct 2001
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH
K013162 · Medcomp · Oct 2001
TRIP TONOMETRY CATHETER, 14F
K993296 · Datex-Ohmeda, Inc. · Dec 1999
NUTRISAFE EXTENSION TUBE
K991918 · Vygon Corp. · Oct 1999
BARD BALLOON INFLATION SYSTEM
K991375 · C.R. Bard, Inc. · Sep 1999