Cleared Traditional

K082357 - MICROLIFE UPPER ARM AUTOMATIC DIGITAL B...

K082357 is an FDA 510(k) clearance for MICROLIFE UPPER ARM AUTOMATIC DIGITAL B..., manufactured by Microlife Intellectual Property GmbH. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K082357 · Microlife Intellectual Property GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
72d
Days
Class 2
Risk

K082357 is an FDA 510(k) clearance for the MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OF.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Microlife Intellectual Property GmbH (Great Neck, US). The FDA issued a Cleared decision on October 29, 2008 after a review of 72 days - a notably fast clearance cycle.

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: 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 Microlife Intellectual Property GmbH devices

FDA 510(k) Submission Details - K082357

510(k) Number K082357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2008
Decision Date October 29, 2008
Days to Decision 72 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
53d faster than avg
Panel avg: 125d · This submission: 72d
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 565
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K082357.
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941
K083319 · Andon Health Co, Ltd. · Jan 2009
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3
K082881 · Microlife Intellectual Property GmbH · Nov 2008
A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR
K082734 · A&D Engineering, Inc. · Nov 2008
HEM-9000AI
K081654 · Omron Healthcare, Inc. · Oct 2008
KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080326 · Andon Health Co, Ltd. · Jul 2008
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080319 · Andon Health Co, Ltd. · Jul 2008