Cleared Traditional

K220781 - ARMADA Ureteral Dilator Set

K220781 is an FDA 510(k) clearance for ARMADA Ureteral Dilator Set, manufactured by Allwin Medical Devices, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZN cleared through the Traditional 510(k) pathway after a 414-day FDA review.

K220781 · Allwin Medical Devices, Inc. · Gastroenterology & Urology device
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May 2023
Decision
414d
Days
Class 2
Risk

K220781 is an FDA 510(k) clearance for the ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Ampla.... Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on May 5, 2023 after a review of 414 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Allwin Medical Devices, Inc. devices

FDA 510(k) Submission Details - K220781

510(k) Number K220781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2022
Decision Date May 05, 2023
Days to Decision 414 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
284d slower than avg
Panel avg: 130d · This submission: 414d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZN Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K220781.
Optilume® High Pressure Urological Balloon Dilation Catheter
K250910 · Urotronic, Inc. · May 2025
In-Ka Ureteral Balloon Dilatation Catheter
K201007 · Coloplast Corp. · Jun 2020
EQUINOX Balloon Dilatation Catheter
K190612 · Dornier Medtech America, Inc. · Dec 2019
Ureteral Dilator Sets, Ureteral Dilators
K173654 · Cook Incorporated · Jul 2018
Safety Wire Guide Introducer
K180756 · Cook Incorporated · May 2018
Cook 810 Set, Desilets-Hoffman Introducer Set
K180028 · Cook Incorporated · May 2018