Cleared Special

K072862 - BOSTON-BAND CRANIAL REMODLING ORTHOSIS

K072862 is an FDA 510(k) clearance for BOSTON-BAND CRANIAL REMODLING ORTHOSIS, manufactured by Boston Brace Intl., Inc.. The device is a Class 2 Neurology device with product code OAN cleared through the Special 510(k) pathway after a 109-day FDA review.

K072862 · Boston Brace Intl., Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
109d
Days
Class 2
Risk

K072862 is an FDA 510(k) clearance for the BOSTON-BAND CRANIAL REMODLING ORTHOSIS. Classified as Orthosis, Cranial, Laser Scan (product code OAN), Class II - Special Controls.

Submitted by Boston Brace Intl., Inc. (Avon, US). The FDA issued a Cleared decision on January 22, 2008 after a review of 109 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072862

510(k) Number K072862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2007
Decision Date January 22, 2008
Days to Decision 109 days
Submission Type Special
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
40d faster than avg
Panel avg: 149d · This submission: 109d
Pathway characteristics
Modification to existing cleared device.

OAN Device Classification - Class 2, Special Controls

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 K072862.
STARBAND
K082950 · Orthomerica Products, Inc. · Dec 2008
STARLIGHT
K082945 · Orthomerica Products, Inc. · Oct 2008
STARLIGHT
K081994 · Orthomerica Products, Inc. · Sep 2008
HANGER CRANIAL BAND
K072566 · Hanger Prosthetics & Orthotics, Inc. · Jan 2008
STATIC CRANIOPLASTY ORTHOSIS
K063098 · Boston Brace Intl., Inc. · Apr 2007
CLARREN HELMET (ORTHOMERICA)
K021918 · Orthomerica Products, Inc. · Jul 2002
K072862 · BOSTON-BAND CRANIAL REMODLING ORTHOSIS
Download PDF FDA Summary Boston Brace Intl., I…