Cleared Traditional

K103362 - AOI CRANIAL HELMET

K103362 is an FDA 510(k) clearance for AOI CRANIAL HELMET, manufactured by Advanced Orthopro, Inc.. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K103362 · Advanced Orthopro, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
152d
Days
Class 2
Risk

K103362 is an FDA 510(k) clearance for the AOI CRANIAL HELMET. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Advanced Orthopro, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 18, 2011 after a review of 152 days - an extended review cycle.

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. 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.

FDA 510(k) Submission Details - K103362

510(k) Number K103362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2010
Decision Date April 18, 2011
Days to Decision 152 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
3d slower than avg
Panel avg: 149d · This submission: 152d
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 K103362.
P-POD
K133397 · P-Pod · Apr 2014
BOSTON BAND
K111609 · Boston Brace Intl., Inc. · Aug 2011
CRANIAL REMOLDING ORTHOSIS
K111247 · Orthotic Care Services, Llp · Aug 2011
MICHIGAN CRANIAL RESHAPING ORTHOSIS
K090341 · Danmar Products, Inc. · Jan 2010
CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
K070694 · Mike Miner · Sep 2007
CRANIAL SOLUTION ORTHOSIS
K063133 · Cranial Solutions · Jul 2007
K103362 · AOI CRANIAL HELMET
Download PDF FDA Summary Advanced Orthopro, In…