Cleared Traditional

K061962 - SURGI-CUF REUSABLE, RS SERIES

K061962 is an FDA 510(k) clearance for SURGI-CUF REUSABLE, manufactured by Ethox International. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K061962 · Ethox International · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
13d
Days
Class 2
Risk

K061962 is an FDA 510(k) clearance for the SURGI-CUF REUSABLE, RS SERIES. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Ethox International (Buffalo, US). The FDA issued a Cleared decision on July 25, 2006 after a review of 13 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 Ethox International devices

FDA 510(k) Submission Details - K061962

510(k) Number K061962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2006
Decision Date July 25, 2006
Days to Decision 13 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
112d faster than avg
Panel avg: 125d · This submission: 13d
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

Intertek Testing Services
NEIL E DEVINE, JR.

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 143
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K061962.
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K063863 · Advantage Medical Cables, Inc. · Mar 2007
TYTAN BLOOD PRESSURE CUFF
K062238 · Tytan Medical Corp. · Sep 2006
AS101, BLOOD PRESSURE CUFF
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K051904 · Suntech Medical, Inc. · Sep 2005