Cleared Traditional

K910479 - ARGYLE POLYURETHANE SALEM SUMP TUBE

K910479 is an FDA 510(k) clearance for ARGYLE POLYURETHANE SALEM SUMP TUBE, manufactured by Sherwood Medical Co.. The device is a Class 2 Gastroenterology & Urology device with product code BSS cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K910479 · Sherwood Medical Co. · Gastroenterology & Urology device
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Apr 1991
Decision
72d
Days
Class 2
Risk

K910479 is an FDA 510(k) clearance for the ARGYLE POLYURETHANE SALEM SUMP TUBE. Classified as Tube, Nasogastric (product code BSS), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on April 19, 1991 after a review of 72 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K910479

510(k) Number K910479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1991
Decision Date April 19, 1991
Days to Decision 72 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 131d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSS Device Classification - Class 2, Special Controls

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

All 8
Devices cleared under the same product code (BSS) and FDA review panel - the closest regulatory comparables to K910479.
MOSS TUBES, INC. NASAL TUBE - MARK IV
K984629 · Moss Tubes, Inc. · Mar 1999
ASPISAFE GASTRIC TUBE
K961711 · B.Braun Medical, Inc. · Jun 1997
GASTRIC, CATHETER, IRRIGATION & ASPIRATION
K933596 · Polamedco, Inc. · Feb 1995
WILTEK NASAL BILIARY DRAINAGE SET
K894870 · Wiltek Medical, Inc. · Dec 1989
TECNOL NASO-GASTRIC TUBE HOLDER
K891187 · Tecnol New Jersey Wound Care, Inc. · May 1989
FLEXIFLO ENTERAL PUMP SET
K791531 · Abbott Laboratories · Sep 1979