Cleared Special

K120144 - VITAL SIGNS MONITOR

K120144 is an FDA 510(k) clearance for VITAL SIGNS MONITOR, manufactured by Edan Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 27-day FDA review.

K120144 · Edan Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
27d
Days
Class 2
Risk

K120144 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on February 14, 2012 after a review of 27 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120144

510(k) Number K120144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2012
Decision Date February 14, 2012
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 1127
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K120144.
BLOOD PRESSURE MONITOR
K112691 · Nihon Seimitsu Sokki Co., Ltd. · Feb 2012
BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR
K111141 · Wenzhou Bokang Instruments Co., Ltd. · Feb 2012
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
K120132 · Philips Medical Systems · Feb 2012
KINGYIELD WRIST BLOOD PRESSURE MONITOR
K112042 · Shenzhen Kingyield Technology Co., Ltd. · Feb 2012
TRANSTEK BLOOD PRESSURE MONITOR
K120058 · Zhongshan Transtek Electronics Co., Ltd. · Jan 2012
MODEL HBP-1300
K113185 · Omron Healthcare, Inc. · Jan 2012
K120144 · VITAL SIGNS MONITOR
Download PDF FDA Summary Edan Instruments, Inc.