Cleared Traditional

K122098 - APPS-HEALTH01

K122098 is an FDA 510(k) clearance for APPS-HEALTH01, manufactured by Andon Health Co, Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K122098 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
248d
Days
Class 2
Risk

K122098 is an FDA 510(k) clearance for the APPS-HEALTH01. 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 March 21, 2013 after a review of 248 days - an extended review cycle.

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 Andon Health Co, Ltd. devices

FDA 510(k) Submission Details - K122098

510(k) Number K122098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2012
Decision Date March 21, 2013
Days to Decision 248 days
Submission Type Traditional
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
123d slower than avg
Panel avg: 125d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 717
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K122098.
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K131346 · Microlife Intellectual Property GmbH · Jun 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K131121 · Health & Life Co., Ltd. · May 2013
NEXFIN MODEL 2
K122381 · Edwards Lifesciences, LLC · Apr 2013
BP652N (HEM-6300-Z)
K123498 · Omron Healthcare, Inc. · Mar 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
K123073 · Grandway Technology (Shenzhen) Limited · Mar 2013
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
K120673 · Grandway Technology (Shenzhen) Limited · Feb 2013