Cleared Traditional

K962688 - MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K962688 · Boston Medical Products, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
14d
Days
Class 1
Risk

K962688 is an FDA 510(k) clearance for the MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE. Classified as Dilator, Esophageal, Ent (product code KCF), Class I - General Controls.

Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 14 days - a notably fast clearance cycle.

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: 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 Boston Medical Products, Inc. devices

Submission Details

510(k) Number K962688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1996
Decision Date July 25, 1996
Days to Decision 14 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 89d · This submission: 14d
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.