Cleared Traditional

K123882 - AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR

K123882 is an FDA 510(k) clearance for AGE AUTOMATIC UPPER ARM BLOOD PRESSURE ..., manufactured by Ageless Health Industrial. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K123882 · Ageless Health Industrial · Cardiovascular device
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Aug 2013
Decision
240d
Days
Class 2
Risk

K123882 is an FDA 510(k) clearance for the AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Ageless Health Industrial (Dongguan, Guangdong, CN). The FDA issued a Cleared decision on August 14, 2013 after a review of 240 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 Ageless Health Industrial devices

FDA 510(k) Submission Details - K123882

510(k) Number K123882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2012
Decision Date August 14, 2013
Days to Decision 240 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
115d slower than avg
Panel avg: 125d · This submission: 240d
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 845
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