Cleared Traditional

K926038 - FLEX-TECH BALLOON DILATOR

K926038 is an FDA 510(k) clearance for FLEX-TECH BALLOON DILATOR, manufactured by Cape Tech Medical Products. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K926038 · Cape Tech Medical Products · Gastroenterology & Urology device
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Oct 1993
Decision
328d
Days
Class 2
Risk

K926038 is an FDA 510(k) clearance for the FLEX-TECH BALLOON DILATOR. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Cape Tech Medical Products (Falmouth, US). The FDA issued a Cleared decision on October 25, 1993 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cape Tech Medical Products devices

FDA 510(k) Submission Details - K926038

510(k) Number K926038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date October 25, 1993
Days to Decision 328 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 131d · This submission: 328d
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 K926038.
MICROVASIVE MAXFORCE
K934697 · Boston Scientific Corp · May 1994
TRI-MED INFLATABLE ESOPHAGEAL DILATOR
K932015 · Tri-Med Specialties, Inc. · Feb 1994
OLYMPUS SCLEROTHERAPY BALLOON
K933992 · Olympus Corp. · Dec 1993
WILSON-COOK BALLOON DILATION CATHETERS
K900924 · Wilson-Cook Medical, Inc. · Dec 1990
ESOPHAGEAL BALLOON DILATOR
K901424 · Telemed Systems, Inc. · Jun 1990
PORGES STEPPED NEOPLEX DILATOR
K883526 · Porges Corp. · Oct 1988