Cleared Traditional

K112825 - AVITA ARM TYPE BLOOD PRESSURE MONITOR

K112825 is an FDA 510(k) clearance for AVITA ARM TYPE BLOOD PRESSURE MONITOR, manufactured by Avita Corporation. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K112825 · Avita Corporation · Cardiovascular device
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Jan 2012
Decision
112d
Days
Class 2
Risk

K112825 is an FDA 510(k) clearance for the AVITA ARM TYPE BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Avita Corporation (Flagstaff, US). The FDA issued a Cleared decision on January 18, 2012 after a review of 112 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. 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 Avita Corporation devices

FDA 510(k) Submission Details - K112825

510(k) Number K112825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2011
Decision Date January 18, 2012
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
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 844
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