Cleared Traditional

K192283 - MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator

K192283 is an FDA 510(k) clearance for MEDRON Vessel Dilator - 6F x 22cm HDPE ..., manufactured by Medron, LLC. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K192283 · Medron, LLC · Cardiovascular device
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May 2020
Decision
258d
Days
Class 2
Risk

K192283 is an FDA 510(k) clearance for the MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F.... Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Medron, LLC (Salt Lake City, US). The FDA issued a Cleared decision on May 6, 2020 after a review of 258 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medron, LLC devices

FDA 510(k) Submission Details - K192283

510(k) Number K192283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2019
Decision Date May 06, 2020
Days to Decision 258 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 125d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRE Dilator, Vessel, For Percutaneous Catheterization

All 79
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K192283.
Xtractor device
K211679 · Xcardia Innovation , Ltd. · Feb 2022
Endovascular Dilator and Sets
K210734 · Cook Incorporated · Apr 2021
ExpanSure Large Access Transseptal Dilator
K201288 · Baylis Medical Company, Inc. · Jun 2020
Super Sheath
K200379 · Togo Medikit Co., Ltd. · Mar 2020
Sterile Dilator
K192195 · Galt Medical Corp. · Sep 2019
S-MAK XL
K190175 · Merit Medical Systems, Inc. · Apr 2019