Cleared Traditional

SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF (K120125) - FDA 510(k) Clearance

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

K120125 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular device
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Oct 2012
Decision
260d
Days
Class 2
Risk

K120125 is an FDA 510(k) clearance for the SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 3, 2012 after a review of 260 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Medical Systems Information Technologies, Inc. devices

Submission Details

510(k) Number K120125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date October 03, 2012
Days to Decision 260 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
135d slower than avg
Panel avg: 125d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 60
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K120125.
Accutension Smartphone Auscultatory Blood
K180335 · Shanghai Hulu Devices Co., Ltd. · Mar 2018
Medline Singe Patient Use Blood Pressure Cuff
K161035 · Medline Industries, Inc. · Jun 2016
FLEXIPORT ECOCUFF
K122058 · Welch Allyn, Inc. · Nov 2012
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244 · Medline Industries, Inc. · Mar 2008
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
K070060 · Welch Allyn, Inc. · Dec 2007
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
K022482 · Ge Medical Systems Information Technologies · Aug 2002