Cleared Traditional

K984629 - MOSS TUBES

K984629 is the FDA 510(k) clearance for MOSS TUBES by Moss Tubes, Inc.. It is a Class 2 Gastroenterology & Urology device (product code BSS) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K984629 · Moss Tubes, Inc. · Gastroenterology & Urology device
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Mar 1999
Decision
62d
Days
Class 2
Risk

K984629 is an FDA 510(k) clearance for the MOSS TUBES, INC. NASAL TUBE - MARK IV. Classified as Tube, Nasogastric (product code BSS), Class II - Special Controls.

Submitted by Moss Tubes, Inc. (Elizabeth, US). The FDA issued a Cleared decision on March 2, 1999 after a review of 62 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 Moss Tubes, Inc. devices

Submission Details

510(k) Number K984629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1998
Decision Date March 02, 1999
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSS Tube, Nasogastric
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 - BSS Tube, Nasogastric

Devices cleared under the same product code (BSS) and FDA review panel - the closest regulatory comparables to K984629.
ENTERAL FEEDING TUBE
K051480 · Biosearch Medical Products, Inc. · Oct 2005
ASPISAFE GASTRIC TUBE
K961711 · B.Braun Medical, Inc. · Jun 1997
ARGYLE POLYURETHANE SALEM SUMP TUBE
K910479 · Sherwood Medical Co. · Apr 1991
TECNOL NASO-GASTRIC TUBE HOLDER
K891187 · Tecnol New Jersey Wound Care, Inc. · May 1989
FLEXIFLO ENTERAL PUMP SET
K791531 · Abbott Laboratories · Sep 1979