Cleared Traditional

HANGER CRANIAL BAND (K072566) - FDA 510(k) Clearance

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

K072566 · Hanger Prosthetics & Orthotics, Inc. · Neurology device
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Jan 2008
Decision
119d
Days
Class 2
Risk

K072566 is an FDA 510(k) clearance for the HANGER CRANIAL BAND. Classified as Orthosis, Cranial, Laser Scan (product code OAN), Class II - Special Controls.

Submitted by Hanger Prosthetics & Orthotics, Inc. (Washington, US). The FDA issued a Cleared decision on January 9, 2008 after a review of 119 days - within the typical 510(k) review window.

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 Hanger Prosthetics & Orthotics, Inc. devices

Submission Details

510(k) Number K072566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2007
Decision Date January 09, 2008
Days to Decision 119 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
29d faster than avg
Panel avg: 148d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAN Orthosis, Cranial, Laser Scan
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5970
Definition A Cranial Orthosis Is A Device That Is Intended For Medical Purposes To Apply Pressure To Prominent Regions Of An Infant's Cranium In Order To Improve Cranial Symmetry And/or Shape. A Laser Scanning Accessory May Be Used To Create A Scan Of The Infant's Head. Indicated For Infants From 3 To 18 Months Of Age, With Moderate To Severe Nonsynostotic Positional Plagiocephaly, Including Infants With Plagiocephalic-, Brachycephalic-, And Scaphocephalic-shaped Heads.
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 - OAN Orthosis, Cranial, Laser Scan

All 22
Devices cleared under the same product code (OAN) and FDA review panel - the closest regulatory comparables to K072566.
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