Cleared Special

K092806 - AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770

K092806 is an FDA 510(k) clearance for AUTO DIGITAL UPPER ARM BLOOD PRESSURE M..., manufactured by K-Jump Health Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 28-day FDA review.

K092806 · K-Jump Health Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K092806

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
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 1206
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K092806.
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C
K092456 · Microlife Intellectual Property GmbH · Oct 2009
VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH
K091414 · Biocare Corp. · Oct 2009
AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)
K092432 · Jawon Medical Co., Ltd. · Oct 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF
K092161 · Health & Life Co., Ltd. · Sep 2009
DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
K092683 · Shanghai Little Doctor Co. Limited · Sep 2009
BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE
K091553 · Ningbo Diaier Electronic Co., Ltd. · Sep 2009
K092806 · AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
Download PDF FDA Summary K-Jump Health Co., Lt…