Cleared Traditional

HASKAL TORQUE DEVICE (K100425) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100425 · Elcam Medical Acal · Cardiovascular device
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Jun 2010
Decision
121d
Days
Class 2
Risk

K100425 is an FDA 510(k) clearance for the HASKAL TORQUE DEVICE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on June 17, 2010 after a review of 121 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 Elcam Medical Acal devices

Submission Details

510(k) Number K100425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date June 17, 2010
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 288
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K100425.
APPROACH PRO ST WIRE GUIDE
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K110009 · Cook, Inc. · Feb 2011
ARCHER SUPER STIFF GUIDEWIRES
K101339 · Medtronic, Inc. · Aug 2010
GTX 12 GIDEWIRE
K100470 · Medtronic, Inc. · Apr 2010
NEUROSCOUT STEERABLE GUIDEWIRE
K100351 · Codman & Shurtleff, Inc. · Mar 2010
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
K091582 · Medtronic Vascular · Dec 2009