Cleared Traditional

K140353 - STARBAND AND STARLIGHT

K140353 is an FDA 510(k) clearance for STARBAND AND STARLIGHT, manufactured by Orthomerica Products, Inc.. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K140353 · Orthomerica Products, Inc. · Neurology device
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Jun 2014
Decision
114d
Days
Class 2
Risk

K140353 is an FDA 510(k) clearance for the STARBAND AND STARLIGHT. 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 June 6, 2014 after a review of 114 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 Orthomerica Products, Inc. devices

FDA 510(k) Submission Details - K140353

510(k) Number K140353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2014
Decision Date June 06, 2014
Days to Decision 114 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
35d faster than avg
Panel avg: 149d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVA Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K140353.
MyCRO Band
K201426 · Otto Bock Healthcare LP · Mar 2021
KidCap
K180568 · Eastern Cranial Affiliates, LLC · Oct 2018
STARBAND, STARLIGHT
K141842 · Orthomerica Products, Inc. · Oct 2014
P-POD
K133397 · P-Pod · Apr 2014
BOSTON BAND
K111609 · Boston Brace Intl., Inc. · Aug 2011
CRANIAL REMOLDING ORTHOSIS
K111247 · Orthotic Care Services, Llp · Aug 2011