Cleared Traditional

K901424 - ESOPHAGEAL BALLOON DILATOR

K901424 is an FDA 510(k) clearance for ESOPHAGEAL BALLOON DILATOR, manufactured by Telemed Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K901424 · Telemed Systems, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
87d
Days
Class 2
Risk

K901424 is an FDA 510(k) clearance for the ESOPHAGEAL BALLOON DILATOR. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on June 21, 1990 after a review of 87 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 Telemed Systems, Inc. devices

FDA 510(k) Submission Details - K901424

510(k) Number K901424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date June 21, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 131d · This submission: 87d
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 34
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K901424.
OLYMPUS SCLEROTHERAPY BALLOON
K933992 · Olympus Corp. · Dec 1993
FLEX-TECH BALLOON DILATOR
K926038 · Cape Tech Medical Products · Oct 1993
WILSON-COOK BALLOON DILATION CATHETERS
K900924 · Wilson-Cook Medical, Inc. · Dec 1990
PORGES STEPPED NEOPLEX DILATOR
K883526 · Porges Corp. · Oct 1988
KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K862000 · Keymed, Inc. · Aug 1986
AMERICAN DILATATION SYSTEM
K853274 · American Endoscopy, Inc. · Oct 1985