Cleared Traditional

K203098 - STARband

K203098 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 195-day FDA review.

K203098 · Orthomerica Products, Inc. · Neurology device
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Apr 2021
Decision
195d
Days
Class 2
Risk

K203098 is an FDA 510(k) clearance for the STARband, STARlight, St. Louis Band. 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 April 27, 2021 after a review of 195 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 Orthomerica Products, Inc. devices

FDA 510(k) Submission Details - K203098

510(k) Number K203098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2020
Decision Date April 27, 2021
Days to Decision 195 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
47d slower than avg
Panel avg: 148d · This submission: 195d
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.