Cleared Abbreviated

K040159 - APM BLOOD PRESSURE MONITOR

K040159 is the FDA 510(k) clearance for APM BLOOD PRESSURE MONITOR by Asia Pacific Microsystems, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Abbreviated 510(k) pathway after a 59-day FDA review.

K040159 · Asia Pacific Microsystems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
59d
Days
Class 2
Risk

K040159 is an FDA 510(k) clearance for the APM BLOOD PRESSURE MONITOR, MODEL BP108A. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Asia Pacific Microsystems, Inc. (Hsin Chu City, TW). The FDA issued a Cleared decision on March 22, 2004 after a review of 59 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Asia Pacific Microsystems, Inc. devices

Submission Details

510(k) Number K040159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2004
Decision Date March 22, 2004
Days to Decision 59 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Standards-based clearance path.

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 K040159.
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