Cleared Special

K071960 - MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05

K071960 is an FDA 510(k) clearance for MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, manufactured by Meditech Kft.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 18-day FDA review.

K071960 · Meditech Kft. · Cardiovascular device
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Aug 2007
Decision
18d
Days
Class 2
Risk

K071960 is an FDA 510(k) clearance for the MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Meditech Kft. (Mitzpe Aviv, IL). The FDA issued a Cleared decision on August 3, 2007 after a review of 18 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.

View all Meditech Kft. devices

FDA 510(k) Submission Details - K071960

510(k) Number K071960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2007
Decision Date August 03, 2007
Days to Decision 18 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
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 846
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