Cleared Traditional

K122058 - FLEXIPORT ECOCUFF

K122058 is an FDA 510(k) clearance for FLEXIPORT ECOCUFF, manufactured by Welch Allyn, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K122058 · Welch Allyn, Inc. · Cardiovascular device
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Nov 2012
Decision
115d
Days
Class 2
Risk

K122058 is an FDA 510(k) clearance for the FLEXIPORT ECOCUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on November 5, 2012 after a review of 115 days - within the typical 510(k) review window.

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 Welch Allyn, Inc. devices

FDA 510(k) Submission Details - K122058

510(k) Number K122058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2012
Decision Date November 05, 2012
Days to Decision 115 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 115
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K122058.
ANDON BLOOD PRESSURE CUFF
K133117 · Andon Health Co, Ltd. · Mar 2014
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF
K130942 · Legacy Medical, Inc. · Oct 2013
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
K123996 · Ge Medical Systems Information Technologies, Inc. · Apr 2013
SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
K120125 · Ge Medical Systems Information Technologies, Inc. · Oct 2012
BLOOD PRESSURE MONITOR WITH STETHOSCOPE
K122259 · Hangzhou Reli-On Co., Ltd. · Sep 2012
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364 · Unimed Medical Supplies, Inc. · May 2012