Cleared Traditional

K972372 - GERM TRAPPER SUCTION TUBE HOLDER (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972372 · Rzv Medical Specialties, Inc. · General Hospital
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Dec 1997
Decision
169d
Days
Class 2
Risk

K972372 is an FDA 510(k) clearance for the GERM TRAPPER SUCTION TUBE HOLDER. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Rzv Medical Specialties, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on December 11, 1997 after a review of 169 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Rzv Medical Specialties, Inc. devices

Submission Details

510(k) Number K972372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1997
Decision Date December 11, 1997
Days to Decision 169 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 128d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.