Cleared Traditional

K090341 - MICHIGAN CRANIAL RESHAPING ORTHOSIS

K090341 is an FDA 510(k) clearance for MICHIGAN CRANIAL RESHAPING ORTHOSIS, manufactured by Danmar Products, Inc.. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K090341 · Danmar Products, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K090341

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 149d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVA Device Classification - Class 2, Special Controls

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
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K090341.
BOSTON BAND
K111609 · Boston Brace Intl., Inc. · Aug 2011
CRANIAL REMOLDING ORTHOSIS
K111247 · Orthotic Care Services, Llp · Aug 2011
AOI CRANIAL HELMET
K103362 · Advanced Orthopro, Inc. · Apr 2011
CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
K070694 · Mike Miner · Sep 2007
CRANIAL SOLUTION ORTHOSIS
K063133 · Cranial Solutions · Jul 2007
O&P BIVALVE CRANIAL MOLDING HELMET
K063395 · Orthotic & Prosthetic Lab, Inc. · Dec 2006
K090341 · MICHIGAN CRANIAL RESHAPING ORTHOSIS
Download PDF FDA Summary Danmar Products, Inc.