Cleared Traditional

Arm-type Electronic Blood Pressure Monitor (K183058) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183058 · Shenzhen Bsx Technology Electronics Co., Ltd. · Cardiovascular device
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Jul 2019
Decision
243d
Days
Class 2
Risk

K183058 is an FDA 510(k) clearance for the Arm-type Electronic Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Shenzhen Bsx Technology Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 3, 2019 after a review of 243 days - an extended review cycle.

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 Shenzhen Bsx Technology Electronics Co., Ltd. devices

Submission Details

510(k) Number K183058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2018
Decision Date July 03, 2019
Days to Decision 243 days
Submission Type Traditional
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
118d slower than avg
Panel avg: 125d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 269
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K183058.
Non-invasive blood pressure measurement systems
K190886 · Joytech Healthcare Co. , Ltd. · Jul 2019
Digital Automatic Blood Pressure Monitor MD36 Series
K191593 · Grandway Technology (Shenzhen) Limited · Jul 2019
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K190818 · Microlife Intellectual Property GmbH · Jul 2019
Oscillometric Blood Pressure Monitor
K190927 · Rudolf Riester GmbH · Jun 2019
The ClearSight finger cuffs
K190130 · Edwards Lifesciences, LLC · Jun 2019
Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
K190133 · Health & Life Co., Ltd. · Jun 2019