Cleared Traditional

K103493 - HEAD FIATION DEVICE (HFD 100)

K103493 is an FDA 510(k) clearance for HEAD FIATION DEVICE (HFD 100), manufactured by Imris, Inc.. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K103493 · Imris, Inc. · Neurology device
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Mar 2011
Decision
102d
Days
Class 2
Risk

K103493 is an FDA 510(k) clearance for the HEAD FIATION DEVICE (HFD 100). Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Imris, Inc. (Rockville, US). The FDA issued a Cleared decision on March 11, 2011 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - 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 Imris, Inc. devices

FDA 510(k) Submission Details - K103493

510(k) Number K103493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2010
Decision Date March 11, 2011
Days to Decision 102 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
46d faster than avg
Panel avg: 148d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBL Device Classification - Class 2, Special Controls

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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 - HBL Holder, Head, Neurosurgical (skull Clamp)

All 33
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