Cleared Traditional

K020184 - HOMMED CENTRAL STATION

K020184 is an FDA 510(k) clearance for HOMMED CENTRAL STATION, manufactured by Hommed, LLC. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K020184 · Hommed, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
94d
Days
Class 2
Risk

K020184 is an FDA 510(k) clearance for the HOMMED CENTRAL STATION. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Hommed, LLC (Houston, US). The FDA issued a Cleared decision on April 22, 2002 after a review of 94 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 Hommed, LLC devices

FDA 510(k) Submission Details - K020184

510(k) Number K020184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2002
Decision Date April 22, 2002
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 745
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K020184.
WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
K023495 · Welch Allyn, Inc. · Oct 2002
WELCH ALLYN ABPM 6100
K021756 · Welch Allyn, Inc. · Jun 2002
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
K021225 · Rossmax International , Ltd. · May 2002
HL168F
K020766 · Health & Life Co., Ltd. · Apr 2002
ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K014204 · K-Jump Health Co., Ltd. · Mar 2002
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS
K012472 · A&D Engineering, Inc. · Feb 2002