Cleared Traditional

K842637 - UNIFLOW VENT TUBE

K842637 is an FDA 510(k) clearance for UNIFLOW VENT TUBE, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K842637 · Richards Medical Co., Inc. · Ear, Nose, Throat device
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Oct 1984
Decision
108d
Days
Class 2
Risk

K842637 is an FDA 510(k) clearance for the UNIFLOW VENT TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on October 25, 1984 after a review of 108 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K842637

510(k) Number K842637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1984
Decision Date October 25, 1984
Days to Decision 108 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 89d · This submission: 108d
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 68
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K842637.
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
K852387 · Xomed, Inc. · Jan 1986
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
K853641 · Xomed, Inc. · Jan 1986
TYMPANOSTOMY TUBES-VARIOUS
K833246 · Abco Dealers, Inc. · Jan 1985
DONALDSON VENT TUBE
K823910 · Treace Medical, Inc. · Nov 1983
TSH RIA
K833910 · Syncor Intl. Corp. · Nov 1983
CONCEPT T-TUBE
K832361 · Concept, Inc. · Oct 1983