Cleared Abbreviated

Arm Blood Pressure Monitor (K192023) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K192023 · Truly Instrument Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
147d
Days
Class 2
Risk

K192023 is an FDA 510(k) clearance for the Arm Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Truly Instrument Limited (Shanwei, CN). The FDA issued a Cleared decision on December 23, 2019 after a review of 147 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.

View all Truly Instrument Limited devices

Submission Details

510(k) Number K192023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date December 23, 2019
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
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 Consultant

Truly (U.S.A), Inc.
Max Wong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 285
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K192023.
Globalcare Blood Pressure Monitor
K192609 · Globalcare Medical Technology Co., Ltd. · Apr 2020
Upper Arm Blood Pressure Monitor
K191894 · Shenzhen Zhengkang Technology Co., Ltd. · Feb 2020
Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
K192092 · Seca GmbH & Co. KG · Jan 2020
Upper Arm Blood Pressure Monitor
K191673 · Famidoc Technology Company Limited · Nov 2019
Full Automatic (NIBP) Blood Pressure Monitor
K190507 · Health & Life Co., Ltd. · Sep 2019
CNAP Monitor
K183521 · Cnsystems Medizintechnik GmbH · Sep 2019