Cleared Abbreviated

K161846 - Automatic Arm Bluetooth Blood Pressure Monitor

K161846 is an FDA 510(k) clearance for Automatic Arm Bluetooth Blood Pressure ..., manufactured by Truly Instrument Limited. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Abbreviated 510(k) pathway after a 111-day FDA review.

K161846 · Truly Instrument Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
111d
Days
Class 2
Risk

K161846 is an FDA 510(k) clearance for the Automatic Arm Bluetooth 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 October 24, 2016 after a review of 111 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

FDA 510(k) Submission Details - K161846

510(k) Number K161846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date October 24, 2016
Days to Decision 111 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
14d faster than avg
Panel avg: 125d · This submission: 111d
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 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 1010
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K161846.
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V10
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