Cleared Traditional

K904592 - BOBBIN STYLE VENTURI

K904592 is an FDA 510(k) clearance for BOBBIN STYLE VENTURI, manufactured by River Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K904592 · River Medical, Inc. · Ear, Nose, Throat device
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Jan 1991
Decision
110d
Days
Class 2
Risk

K904592 is an FDA 510(k) clearance for the BOBBIN STYLE VENTURI. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by River Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on January 28, 1991 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all River Medical, Inc. devices

FDA 510(k) Submission Details - K904592

510(k) Number K904592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1990
Decision Date January 28, 1991
Days to Decision 110 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 89d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETD Device Classification - Class 2, Special Controls

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETD Tube, Tympanostomy

All 69
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K904592.
TITANIUM VENTILATION TUBES
K921923 · Exmoor Plastics , Ltd. · Feb 1993
DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES
K911580 · Exmoor Plastics , Ltd. · Sep 1991
SUH VENT TUBE
K910618 · Boston Medical Products, Inc. · Jun 1991
JAHN VENTILATION TUBE
K900267 · Smith & Nephew Richards, Inc. · Jun 1990
PAPPAS TRI-FLANGE VENTILATION TUBE
K895242 · Richards Medical Co., Inc. · Nov 1989
DONALDSON VENTILATION TUBES PT. # AG/S9
K883667 · Exmoor Plastics , Ltd. · Nov 1988