Cleared Traditional

K120119 - SUNMED GUIDE WIRE

K120119 is an FDA 510(k) clearance for SUNMED GUIDE WIRE, manufactured by Sunny Medical Device (Shenzhen) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K120119 · Sunny Medical Device (Shenzhen) Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
115d
Days
Class 2
Risk

K120119 is an FDA 510(k) clearance for the SUNMED GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Sunny Medical Device (Shenzhen) Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on May 11, 2012 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Sunny Medical Device (Shenzhen) Co., Ltd. devices

FDA 510(k) Submission Details - K120119

510(k) Number K120119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date May 11, 2012
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K120119.
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K121745 · Bridgepoint Medical · Jul 2012
NAVIS TORQUER
K112674 · Navis Medical,Inc · Jul 2012
CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
K120298 · St. Jude Medical, Cardiac Rhythm Management Divisi · May 2012
WHOLEY GUIDE WIRE SYSTEM
K120863 · Covidien, LLC · Apr 2012
MANTARAY GUIDEWIRES
K120881 · Bridgepoint Medical · Apr 2012