Cleared Traditional

K081159 - HARVARD MEDICAL DEVICES BLOOD PRESSURE ...

K081159 is the FDA 510(k) clearance for HARVARD MEDICAL DEVICES BLOOD PRESSURE ... by Harvard Medical Devices , Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K081159 · Harvard Medical Devices , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
116d
Days
Class 2
Risk

K081159 is an FDA 510(k) clearance for the HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRAND.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Harvard Medical Devices , Ltd. (Tsimshatsui, Kowloon, HK). The FDA issued a Cleared decision on August 8, 2008 after a review of 116 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 Harvard Medical Devices , Ltd. devices

Submission Details

510(k) Number K081159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date August 08, 2008
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 504
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K081159.
A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR
K082734 · A&D Engineering, Inc. · Nov 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200).
K082357 · Microlife Intellectual Property GmbH · Oct 2008
HEM-9000AI
K081654 · Omron Healthcare, Inc. · Oct 2008
KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080326 · Andon Health Co, Ltd. · Jul 2008
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080319 · Andon Health Co, Ltd. · Jul 2008
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
K073445 · Taidoc Technology Corporation · Apr 2008