Cleared Traditional

K994300 - NASOGASTRIC TUBE HOLDER, MODEL 160

K994300 is an FDA 510(k) clearance for NASOGASTRIC TUBE HOLDER, manufactured by Dale 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 51-day FDA review.

K994300 · Dale Medical Products, Inc. · Gastroenterology & Urology device
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Feb 2000
Decision
51d
Days
Class 2
Risk

K994300 is an FDA 510(k) clearance for the NASOGASTRIC TUBE HOLDER, MODEL 160. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on February 10, 2000 after a review of 51 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dale Medical Products, Inc. devices

FDA 510(k) Submission Details - K994300

510(k) Number K994300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1999
Decision Date February 10, 2000
Days to Decision 51 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
80d faster than avg
Panel avg: 131d · This submission: 51d
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 416
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K994300.
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
MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
K012476 · Applied Medical Technology, Inc. · Aug 2001
GASTRIC LAVAGE VALVE
K990365 · T-Med Vac Corporation · Jul 2000
TRIP TONOMETRY CATHETER, 14F
K993296 · Datex-Ohmeda, Inc. · Dec 1999
NUTRISAFE EXTENSION TUBE
K991918 · Vygon Corp. · Oct 1999
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
K993138 · Ballard Medical Products · Oct 1999