Cleared Traditional

K923355 - PHARYNGEAL SALIVARY BYPASS TUBE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K923355 · Boston Medical Products, Inc. · Ear, Nose, Throat device
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Oct 1992
Decision
90d
Days
Class 1
Risk

K923355 is an FDA 510(k) clearance for the PHARYNGEAL SALIVARY BYPASS TUBE. Classified as Dilator, Esophageal, Ent (product code KCF), Class I - General Controls.

Submitted by Boston Medical Products, Inc. (Waltham, US). The FDA issued a Cleared decision on October 6, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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 K923355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1992
Decision Date October 06, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 89d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCF Dilator, Esophageal, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.