Cleared Traditional

K123842 - LAWMAX DILATOR

K123842 is an FDA 510(k) clearance for LAWMAX DILATOR, manufactured by Lifetech Scientific (Shenzhen) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K123842 · Lifetech Scientific (Shenzhen) Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
193d
Days
Class 2
Risk

K123842 is an FDA 510(k) clearance for the LAWMAX DILATOR. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Lifetech Scientific (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 24, 2013 after a review of 193 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 Lifetech Scientific (Shenzhen) Co., Ltd. devices

FDA 510(k) Submission Details - K123842

510(k) Number K123842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2012
Decision Date June 24, 2013
Days to Decision 193 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 125d · This submission: 193d
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 45
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K123842.
van Andel Dilatation Catheter
K170616 · Cook Incorporated · Apr 2017
VSI StraitSet micro-introducer kit
K161336 · Vascular Solutions, Inc. · Aug 2016
NMI COAXIAL MICROINTRODUCER SET
K132713 · Navilyst Medical, Inc. · Sep 2013
PRELUDE SHEATH INTRODUCER
K130791 · Merit Medical Systems, Inc. · Jun 2013
NMI COAXIAL MICROINTRODUCER SET
K123445 · Navilyst Medical, Inc. · Apr 2013
RETROFLEX DILATOR KIT
K093554 · Edwards Lifesciences, LLC · Apr 2010