Cleared Traditional

MICHIGAN CRANIAL RESHAPING ORTHOSIS (K090341) - FDA 510(k) Clearance

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

K090341 · Danmar Products, Inc. · Neurology device
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Jan 2010
Decision
330d
Days
Class 2
Risk

K090341 is an FDA 510(k) clearance for the MICHIGAN CRANIAL RESHAPING ORTHOSIS. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Danmar Products, Inc. (Dearborn, US). The FDA issued a Cleared decision on January 6, 2010 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5970 - 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 Danmar Products, Inc. devices

Submission Details

510(k) Number K090341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2009
Decision Date January 06, 2010
Days to Decision 330 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
182d slower than avg
Panel avg: 148d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MVA Orthosis, Cranial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5970
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 - MVA Orthosis, Cranial

All 42
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