Cleared Traditional

K834451 - COAXIAL BALLOON GASTROESOPHAGEAL DILA

K834451 is an FDA 510(k) clearance for COAXIAL BALLOON GASTROESOPHAGEAL DILA, manufactured by Thomas J. Fogarty, M.D.. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K834451 · Thomas J. Fogarty, M.D. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 1984
Decision
47d
Days
Class 2
Risk

K834451 is an FDA 510(k) clearance for the COAXIAL BALLOON GASTROESOPHAGEAL DILA. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Thomas J. Fogarty, M.D. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - the FDA gastroenterology and urology 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 Thomas J. Fogarty, M.D. devices

FDA 510(k) Submission Details - K834451

510(k) Number K834451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1983
Decision Date February 04, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 131d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNQ Device Classification - Class 2, Special Controls

Product Code KNQ Dilator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNQ Dilator, Esophageal

All 33
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K834451.
KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K862000 · Keymed, Inc. · Aug 1986
AMERICAN DILATATION SYSTEM
K853274 · American Endoscopy, Inc. · Oct 1985
SAVARY-GILLIARD DILATOR
K851955 · Wilson-Cook Medical, Inc. · Jul 1985
ESOPHAGEAL BOUGIES
K830991 · Medovations, Inc. · Jun 1983
TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR
K830586 · Keymed, Inc. · Mar 1983
CELESTIN DILATOR
K812289 · Inmed Corp. · Sep 1981