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)
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.

View all Clearmedical, Inc. devices

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
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 Peers - DXQ Blood Pressure Cuff

All 113
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K031416.
POLYURETHANE BLOOD PRESSURE CUFFS
K041689 · D. E. Hokanson, Inc. · Aug 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