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)
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.

View all Advanced Orthopro, Inc. devices

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
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 148d · 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 14
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K103362.
KidCap
K180568 · Eastern Cranial Affiliates, LLC · Oct 2018
STARBAND, STARLIGHT
K141842 · Orthomerica Products, Inc. · Oct 2014
STARBAND AND STARLIGHT
K140353 · Orthomerica Products, Inc. · Jun 2014
CRANIAL HELMET
K041215 · Otto Bock Healthcare LP · Sep 2004
OPI BAND
K001167 · Orthomerica Products, Inc. · Jul 2000
DYNAMIC ORTHOTIC CRANIOPLASTY BAND
DEN980001 · Cranial Technologies, Inc. · May 1998