Cleared Traditional

K040002 - MICROLIFE WRIST WATCH BLOOD PRESSURE MO...

K040002 is the FDA 510(k) clearance for MICROLIFE WRIST WATCH BLOOD PRESSURE MO... by Microlife Intellectual Property Gmb. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K040002 · Microlife Intellectual Property Gmb · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
80d
Days
Class 2
Risk

K040002 is an FDA 510(k) clearance for the MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Microlife Intellectual Property Gmb (Great Neck, US). The FDA issued a Cleared decision on March 22, 2004 after a review of 80 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 Gmb devices

Submission Details

510(k) Number K040002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2004
Decision Date March 22, 2004
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 517
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K040002.
WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
K040490 · Welch Allyn, Inc. · Aug 2004
A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR
K040371 · A&D Engineering, Inc. · May 2004
MODEL AVANT 2120 PULSE OXIMETER AND NIBP
K031487 · Nonin Medical, Inc. · Mar 2004
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
K040229 · A&D Engineering, Inc. · Mar 2004
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL
K032305 · Omron Healthcare, Inc. · Feb 2004
A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS
K032499 · A&D Engineering, Inc. · Oct 2003