Cleared Special

K092510 - FULLY AUTOMATIC ELECTRONIC BLOOD PRESSU...

K092510 is the FDA 510(k) clearance for FULLY AUTOMATIC ELECTRONIC BLOOD PRESSU... by Andon Health Co, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 128-day FDA review.

K092510 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
128d
Days
Class 2
Risk

K092510 is an FDA 510(k) clearance for the FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, K.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on December 23, 2009 after a review of 128 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Andon Health Co, Ltd. devices

Submission Details

510(k) Number K092510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2009
Decision Date December 23, 2009
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00952965 Completed Observational Industry-sponsored

Wrist-used Blood Pressure Monitor Clinical Test (Cuff Range: 14cm-25cm)

Clinical Testing Report for Wrist-used Electronic Blood Pressure Monitor

86
Patients (actual)
1
Site
Condition studied Blood Pressure
Eligibility All sexes · 23 Years+ · Healthy volunteers accepted
Principal investigator Qi Sun
Sponsor Andon Health Co., Ltd (industry)
Started 2009-04-01 → Primary completion 2009-07-01
Primary outcome
level of blood pressure
Study completed - no results published. This trial concluded in 2009 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 492
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K092510.
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM
K093823 · Health & Life Co., Ltd. · Jan 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903
K092811 · Andon Health Co, Ltd. · Jan 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918
K092588 · Andon Health Co, Ltd. · Dec 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971
K093452 · Andon Health Co, Ltd. · Dec 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963
K093528 · Andon Health Co, Ltd. · Dec 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902
K093387 · Andon Health Co, Ltd. · Nov 2009