Cleared Abbreviated

K091434 - TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M

K091434 is an FDA 510(k) clearance for TRULY AUTOMATIC ARM BLOOD PRESSURE MONI..., manufactured by Truly Instrument Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Abbreviated 510(k) pathway after a 114-day FDA review.

K091434 · Truly Instrument Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
114d
Days
Class 2
Risk

K091434 is an FDA 510(k) clearance for the TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Truly Instrument Co., Ltd. (Shanwei Shi, Guang Dong, CN). The FDA issued a Cleared decision on September 4, 2009 after a review of 114 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 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.

FDA 510(k) Submission Details - K091434

510(k) Number K091434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2009
Decision Date September 04, 2009
Days to Decision 114 days
Submission Type Abbreviated
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
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Standards-based clearance path.

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 1215
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K091434 · TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M
Download PDF FDA Summary Truly Instrument Co.,…