Cleared Traditional

K110821 - BARF BAND

K110821 · Doodlebug Products, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
340d
Days
-
Risk

K110821 is an FDA 510(k) clearance for the BARF BAND. Classified as Device, Acupressure (product code MVV).

Submitted by Doodlebug Products, LLC (West Newbury, US). The FDA issued a Cleared decision on February 27, 2012 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K110821

510(k) Number K110821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2011
Decision Date February 27, 2012
Days to Decision 340 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
191d slower than avg
Panel avg: 149d · This submission: 340d
Pathway characteristics
Predicate-based equivalence.

MVV Device Classification - Class 0,

Product Code MVV Device, Acupressure
Device Class -

Regulatory Peers - MVV Device, Acupressure

All 12
Devices cleared under the same product code (MVV) and FDA review panel - the closest regulatory comparables to K110821.
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K142471 · Pressure Point, Inc. · Dec 2014
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP
K110563 · Therapeutics 101, Inc (Dba Pressure Point, Inc.) · Apr 2011
PSI BANDS
K070766 · Psi Health Solutions, Inc. · Jul 2007
ACUBAND ACUPRESSURE WRIST BAND DEVICE
K053509 · Acuband, Inc. · Aug 2006
K110821 · BARF BAND
Download PDF FDA Summary Doodlebug Products, L…