Cleared Special

K092806 - AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K092806 · K-Jump Health Co., Ltd. · Cardiovascular device
Oct 2009
Decision
28d
Days
Class 2
Risk

K092806 is an FDA 510(k) clearance for the AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by K-Jump Health Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on October 9, 2009 after a review of 28 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.

Submission Details

510(k) Number K092806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2009
Decision Date October 09, 2009
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 45
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