Cleared Special

K100763 - MICROLIFE UPPER ARM AUTOMATIC DIGITAL B...

K100763 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 Special 510(k) pathway after a 163-day FDA review.

K100763 · Microlife Intellectual Property GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
163d
Days
Class 2
Risk

K100763 is an FDA 510(k) clearance for the MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP .... 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 August 27, 2010 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Microlife Intellectual Property GmbH devices

FDA 510(k) Submission Details - K100763

510(k) Number K100763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2010
Decision Date August 27, 2010
Days to Decision 163 days
Submission Type Special
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
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Modification to existing cleared device.

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 K100763.
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534
K102356 · Andon Health Co, Ltd. · Sep 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513
K102353 · Andon Health Co, Ltd. · Sep 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930
K101950 · Andon Health Co, Ltd. · Aug 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008
K101010 · Andon Health Co, Ltd. · Jul 2010
U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM
K100658 · Taidoc Technology Corporation · Jul 2010
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
K101680 · Welch Allyn, Inc. · Jul 2010