Cleared Abbreviated

K113085 - TRYLY AUTOMATIC WRIST BLOOD PRESSURE MO...

K113085 is the FDA 510(k) clearance for TRYLY AUTOMATIC WRIST BLOOD PRESSURE MO... by Truly Instrument Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Abbreviated 510(k) pathway after a 86-day FDA review.

K113085 · Truly Instrument Co., Ltd. · Cardiovascular device
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Jan 2012
Decision
86d
Days
Class 2
Risk

K113085 is an FDA 510(k) clearance for the TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Truly Instrument Co., Ltd. (Alhambra, US). The FDA issued a Cleared decision on January 12, 2012 after a review of 86 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Truly Instrument Co., Ltd. devices

Submission Details

510(k) Number K113085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2011
Decision Date January 12, 2012
Days to Decision 86 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Standards-based clearance path.

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. 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

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