Cleared Traditional

K223238 - STARband 3D (FDA 510(k) Clearance)

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

K223238 · Orthomerica Products, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2023
Decision
182d
Days
Class 2
Risk

K223238 is an FDA 510(k) clearance for the STARband 3D. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Orthomerica Products, Inc. (Orlando, US). The FDA issued a Cleared decision on April 20, 2023 after a review of 182 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

Submission Details

510(k) Number K223238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2022
Decision Date April 20, 2023
Days to Decision 182 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
34d slower than avg
Panel avg: 148d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 42
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