Cleared Traditional

K111609 - BOSTON BAND

K111609 is an FDA 510(k) clearance for BOSTON BAND, manufactured by Boston Brace Intl., Inc.. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K111609 · Boston Brace Intl., Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
74d
Days
Class 2
Risk

K111609 is an FDA 510(k) clearance for the BOSTON BAND. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Boston Brace Intl., Inc. (Avon, US). The FDA issued a Cleared decision on August 22, 2011 after a review of 74 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.

FDA 510(k) Submission Details - K111609

510(k) Number K111609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2011
Decision Date August 22, 2011
Days to Decision 74 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
75d faster than avg
Panel avg: 149d · This submission: 74d
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 42
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K111609.
STARBAND, STARLIGHT
K141842 · Orthomerica Products, Inc. · Oct 2014
STARBAND AND STARLIGHT
K140353 · Orthomerica Products, Inc. · Jun 2014
P-POD
K133397 · P-Pod · Apr 2014
CRANIAL REMOLDING ORTHOSIS
K111247 · Orthotic Care Services, Llp · Aug 2011
AOI CRANIAL HELMET
K103362 · Advanced Orthopro, Inc. · Apr 2011
MICHIGAN CRANIAL RESHAPING ORTHOSIS
K090341 · Danmar Products, Inc. · Jan 2010
K111609 · BOSTON BAND
Download PDF FDA Summary Boston Brace Intl., I…