Cleared Traditional

BIOBANDS (K051397) - FDA 510(k) Clearance

K051397 · Biobands Distributors, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2005
Decision
112d
Days
-
Risk

K051397 is an FDA 510(k) clearance for the BIOBANDS. Classified as Device, Acupressure (product code MVV).

Submitted by Biobands Distributors, Inc. (Washington, US). The FDA issued a Cleared decision on September 16, 2005 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. 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 Biobands Distributors, Inc. devices

Submission Details

510(k) Number K051397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2005
Decision Date September 16, 2005
Days to Decision 112 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 148d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVV Device, Acupressure
Device Class -