Cleared Traditional

K934348 - TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR

K934348 is an FDA 510(k) clearance for TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE ..., manufactured by Tri-Med Specialties, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code BSS cleared through the Traditional 510(k) pathway after a 472-day FDA review.

K934348 · Tri-Med Specialties, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 1994
Decision
472d
Days
Class 2
Risk

K934348 is an FDA 510(k) clearance for the TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR. Classified as Tube, Nasogastric (product code BSS), Class II - Special Controls.

Submitted by Tri-Med Specialties, Inc. (Overland Park, US). The FDA issued a Cleared decision on December 23, 1994 after a review of 472 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 Tri-Med Specialties, Inc. devices

FDA 510(k) Submission Details - K934348

510(k) Number K934348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date December 23, 1994
Days to Decision 472 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
341d slower than avg
Panel avg: 131d · This submission: 472d
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 9
Devices cleared under the same product code (BSS) and FDA review panel - the closest regulatory comparables to K934348.
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
ARGYLE POLYURETHANE SALEM SUMP TUBE
K910479 · Sherwood Medical Co. · Apr 1991
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