Cleared Traditional

PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP (K110563) - FDA 510(k) Clearance

K110563 · Therapeutics 101, Inc (Dba Pressure Point, Inc.) · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2011
Decision
39d
Days
-
Risk

K110563 is an FDA 510(k) clearance for the PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT .... Classified as Device, Acupressure (product code MVV).

Submitted by Therapeutics 101, Inc (Dba Pressure Point, Inc.) (Austin, US). The FDA issued a Cleared decision on April 8, 2011 after a review of 39 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Therapeutics 101, Inc (Dba Pressure Point, Inc.) devices

Submission Details

510(k) Number K110563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2011
Decision Date April 08, 2011
Days to Decision 39 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
109d faster than avg
Panel avg: 148d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVV Device, Acupressure
Device Class -