Cleared Traditional

K031416 - CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF

Also marketed or referenced as:
CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF

K031416 is an FDA 510(k) clearance for CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF, manufactured by Clearmedical, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K031416 · Clearmedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
71d
Days
Class 2
Risk

K031416 is an FDA 510(k) clearance for the CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Clearmedical, Inc. (Bellevue, US). The FDA issued a Cleared decision on July 15, 2003 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight 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 - K031416

510(k) Number K031416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2003
Decision Date July 15, 2003
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DXQ Device Classification - Class 2, Special Controls

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Citech
ROBERT MOSENKIS

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 - DXQ Blood Pressure Cuff

All 191
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K031416.
BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
K032568 · Med Textile, LLC · Apr 2004
ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
K040286 · Ethox Corp. · Mar 2004
CUF-COVER (TM)
K031195 · Ethox Corp. · Oct 2003
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356 · Card Guard Scientific Survival , Ltd. · Jan 2003
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
K022482 · Ge Medical Systems Information Technologies · Aug 2002
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455 · Welch Allyn, Inc. · Aug 2001
K031416 · CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF
Download PDF FDA Summary Clearmedical, Inc.