Cleared Traditional

K042768 - MEDICOMPASS CONNECT

K042768 is an FDA 510(k) clearance for MEDICOMPASS CONNECT, manufactured by Imetrikus, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K042768 · Imetrikus, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
140d
Days
Class 2
Risk

K042768 is an FDA 510(k) clearance for the MEDICOMPASS CONNECT. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Imetrikus, Inc. (San Diego, US). The FDA issued a Cleared decision on February 22, 2005 after a review of 140 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Imetrikus, Inc. devices

FDA 510(k) Submission Details - K042768

510(k) Number K042768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2004
Decision Date February 22, 2005
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
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 844
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K042768.
DIASYS INTEGRA II
K042109 · Novacor France · Mar 2005
AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600
K050413 · Amplife Corporation · Mar 2005
A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR
K043217 · A&D Engineering, Inc. · Mar 2005
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037
K042818 · Matsushita Electric Works, Ltd. · Jan 2005
AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100
K043550 · Amplife Corporation · Jan 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
K043437 · Health & Life Co., Ltd. · Jan 2005