Cleared Traditional

K842206 - DIAFLEX NEPHROSTOMY BALLOON DILATOR

K842206 is the FDA 510(k) clearance for DIAFLEX NEPHROSTOMY BALLOON DILATOR by American Edwards Laboratories. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K842206 · American Edwards Laboratories · Gastroenterology & Urology device
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Oct 1984
Decision
120d
Days
Class 2
Risk

K842206 is an FDA 510(k) clearance for the DIAFLEX NEPHROSTOMY BALLOON DILATOR. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on October 2, 1984 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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. Standard predicate reliance. 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 American Edwards Laboratories devices

Submission Details

510(k) Number K842206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date October 02, 1984
Days to Decision 120 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
10d faster than avg
Panel avg: 130d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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 - EZN Dilator, Catheter, Ureteral

All 43
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K842206.
URETERAL DILATOR/SHEATH SET
K852793 · American Edwards Laboratories · Aug 1985
URETERAL DILATION SET
K851144 · Van-Tec, Inc. · Apr 1985
MENTOR PERCUTANEOUS RENAL DILATOR SET
K850355 · Mentor Corp. · Mar 1985
DILATOR/SHEATH SET
K842632 · American Edwards Laboratories · Oct 1984
AMER. EDWARDS LAB DIAFLEX URETERAL DILA
K842639 · American Edwards Laboratories · Oct 1984
VAN-TEC URETERAL DILATION BALLOON CATH
K841940 · Van-Tec, Inc. · Aug 1984