Cleared Traditional

K934348 - TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE ...

K934348 is the FDA 510(k) clearance for TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE ... by Tri-Med Specialties, Inc.. It is a Class 2 Gastroenterology & Urology device (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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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

Submission Details

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
342d slower than avg
Panel avg: 130d · This submission: 472d
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 K934348.
ENTERAL FEEDING TUBE
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K891187 · Tecnol New Jersey Wound Care, Inc. · May 1989
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K791531 · Abbott Laboratories · Sep 1979