Cleared Traditional

K122365 - ULTRACHECK CURVE BLOOD PRESSURE CUFFS (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122365 · Statcorp Medical · Cardiovascular device
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Jun 2013
Decision
302d
Days
Class 2
Risk

K122365 is an FDA 510(k) clearance for the ULTRACHECK CURVE BLOOD PRESSURE CUFFS. Classified as Antimicrobial Blood Pressure Cuff (product code OED), Class II - Special Controls.

Submitted by Statcorp Medical (Jacksonville, US). The FDA issued a Cleared decision on June 4, 2013 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K122365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2012
Decision Date June 04, 2013
Days to Decision 302 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 125d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OED Antimicrobial Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition Device Is A Replacement Cuff To Be Used In Conjunction With A Non-invasive Blood Pressure Monitor. Together The Devices Determine Blood Pressures And Heart Rate. This Particular Cuff Contains An Embedded Antimicrobial. 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.