Cleared Traditional

K141842 - STARBAND, STARLIGHT

K141842 is an FDA 510(k) clearance for STARBAND, 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 90-day FDA review.

K141842 · Orthomerica Products, Inc. · Neurology device
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Oct 2014
Decision
90d
Days
Class 2
Risk

K141842 is an FDA 510(k) clearance for the STARBAND, 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 October 6, 2014 after a review of 90 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 - K141842

510(k) Number K141842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2014
Decision Date October 06, 2014
Days to Decision 90 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
59d faster than avg
Panel avg: 149d · This submission: 90d
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 K141842.
SnugKap
K193383 · Headstart, Ltd. · Jun 2021
MyCRO Band
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KidCap
K180568 · Eastern Cranial Affiliates, LLC · Oct 2018
STARBAND AND STARLIGHT
K140353 · Orthomerica Products, Inc. · Jun 2014
P-POD
K133397 · P-Pod · Apr 2014
BOSTON BAND
K111609 · Boston Brace Intl., Inc. · Aug 2011