Cleared Traditional

RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (K962920) - FDA 510(k) Clearance

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

K962920 · R&S Surgical, LLC · General Hospital
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Oct 1996
Decision
87d
Days
Class 2
Risk

K962920 is an FDA 510(k) clearance for the RENTON SUCTION DEVICE U.S. PATENT*4,767,404. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by R&S Surgical, LLC (Georgetown, US). The FDA issued a Cleared decision on October 21, 1996 after a review of 87 days - a notably fast clearance 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: 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 R&S Surgical, LLC devices

Submission Details

510(k) Number K962920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1996
Decision Date October 21, 1996
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
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.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 12
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K962920.
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VAC-RITE
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PLEUR-EVAC A-4005 SYSTEM
K823037 · Howmedica Corp. · Oct 1982
THORACIC DRAINAGE SYSTEM
K821023 · Howmedica Corp. · May 1982