Cleared Traditional

K153519 - DReal

K153519 is an FDA 510(k) clearance for DReal, manufactured by Carevature Medical, Ltd.. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K153519 · Carevature Medical, Ltd. · Neurology device
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Mar 2016
Decision
99d
Days
Class 2
Risk

K153519 is an FDA 510(k) clearance for the DReal. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Carevature Medical, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on March 16, 2016 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carevature Medical, Ltd. devices

FDA 510(k) Submission Details - K153519

510(k) Number K153519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2015
Decision Date March 16, 2016
Days to Decision 99 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 148d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 Neurology devices follow this clearance model.

Regulatory Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 42
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