Cleared Traditional

K924606 - BREMER IMAGING TONGS-MRI MODEL (FDA 510(k) Clearance)

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

K924606 · Bremer Medical, Inc. · Neurology device
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Sep 1993
Decision
363d
Days
Class 2
Risk

K924606 is an FDA 510(k) clearance for the BREMER IMAGING TONGS-MRI MODEL. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Bremer Medical, Inc. (Washington, US). The FDA issued a Cleared decision on September 9, 1993 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5960 - 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. Elevated predicate reliance profile. 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 Bremer Medical, Inc. devices

Submission Details

510(k) Number K924606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1992
Decision Date September 09, 1993
Days to Decision 363 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
215d slower than avg
Panel avg: 148d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAX Tong, Skull For Traction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5960
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.