Cleared Traditional

SUH VENT TUBE (K910618) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910618 · Boston Medical Products, Inc. · Ear, Nose, Throat device
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Jun 1991
Decision
136d
Days
Class 2
Risk

K910618 is an FDA 510(k) clearance for the SUH VENT TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Boston Medical Products, Inc. (Waltham, US). The FDA issued a Cleared decision on June 28, 1991 after a review of 136 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 Boston Medical Products, Inc. devices

Submission Details

510(k) Number K910618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date June 28, 1991
Days to Decision 136 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
47d slower than avg
Panel avg: 89d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K910618.
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · Xomed, Inc. · Jul 1996
VENTILATION TUBES
K960477 · Smith & Nephew, Inc. · Feb 1996
SILICONE TYMPANOSTOMY TUBES
K932166 · Smith & Nephew Richards, Inc. · Jul 1993
JAHN VENTILATION TUBE
K900267 · Smith & Nephew Richards, Inc. · Jun 1990
PUNCH MYRINGOTOMY SYSTEM
K882689 · Xomed, Inc. · Sep 1988
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
K852387 · Xomed, Inc. · Jan 1986