Cleared Traditional

K142471 - Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip

K142471 · Pressure Point, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
89d
Days
-
Risk

K142471 is an FDA 510(k) clearance for the Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist.... Classified as Device, Acupressure (product code MVV).

Submitted by Pressure Point, Inc. (Tinton Falls, US). The FDA issued a Cleared decision on December 1, 2014 after a review of 89 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.

FDA 510(k) Submission Details - K142471

510(k) Number K142471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2014
Decision Date December 01, 2014
Days to Decision 89 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
60d faster than avg
Panel avg: 149d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

MVV Device Classification - Class 0,

Product Code MVV Device, Acupressure
Device Class -

Regulatory Consultant

Emergo Group
Julie Powell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MVV Device, Acupressure

All 12
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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
K142471 · Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip
Download PDF FDA Summary Pressure Point, Inc.