Cleared Traditional

K082950 - STARBAND

K082950 is an FDA 510(k) clearance for STARBAND, manufactured by Orthomerica Products, Inc.. The device is a Class 2 Neurology device with product code OAN cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K082950 · Orthomerica Products, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
63d
Days
Class 2
Risk

K082950 is an FDA 510(k) clearance for the STARBAND. Classified as Orthosis, Cranial, Laser Scan (product code OAN), Class II - Special Controls.

Submitted by Orthomerica Products, Inc. (Orlando, US). The FDA issued a Cleared decision on December 5, 2008 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthomerica Products, Inc. devices

FDA 510(k) Submission Details - K082950

510(k) Number K082950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2008
Decision Date December 05, 2008
Days to Decision 63 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
85d faster than avg
Panel avg: 148d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.