Cleared Traditional

K122013 - MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)

K122013 is an FDA 510(k) clearance for MICROLIFE UPPER ARM AUTOMATIC DIGITAL B..., manufactured by Microlife Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K122013 · Microlife Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
307d
Days
Class 2
Risk

K122013 is an FDA 510(k) clearance for the MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAP.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Microlife Corp. (Great Neck, US). The FDA issued a Cleared decision on May 13, 2013 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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.

View all Microlife Corp. devices

FDA 510(k) Submission Details - K122013

510(k) Number K122013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2012
Decision Date May 13, 2013
Days to Decision 307 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
182d slower than avg
Panel avg: 125d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 630
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K122013.
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K130563 · Health & Life Co., Ltd. · Jun 2013
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K131346 · Microlife Intellectual Property GmbH · Jun 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K131121 · Health & Life Co., Ltd. · May 2013
NEXFIN MODEL 2
K122381 · Edwards Lifesciences, LLC · Apr 2013
APPS-HEALTH01
K122098 · Andon Health Co, Ltd. · Mar 2013
BP652N (HEM-6300-Z)
K123498 · Omron Healthcare, Inc. · Mar 2013