Cleared Traditional

K853274 - AMERICAN DILATATION SYSTEM

K853274 is the FDA 510(k) clearance for AMERICAN DILATATION SYSTEM by American Endoscopy, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNQ) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K853274 · American Endoscopy, Inc. · Gastroenterology & Urology device
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Oct 1985
Decision
73d
Days
Class 2
Risk

K853274 is an FDA 510(k) clearance for the AMERICAN DILATATION SYSTEM. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by American Endoscopy, Inc. (Mentor, US). The FDA issued a Cleared decision on October 17, 1985 after a review of 73 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 American Endoscopy, Inc. devices

Submission Details

510(k) Number K853274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date October 17, 1985
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 22
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K853274.
OLYMPUS SCLEROTHERAPY BALLOON
K933992 · Olympus Corp. · Dec 1993
WILSON-COOK BALLOON DILATION CATHETERS
K900924 · Wilson-Cook Medical, Inc. · Dec 1990
KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K862000 · Keymed, Inc. · Aug 1986
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