Cleared Traditional

Electronic Blood Pressure Monitor (K212171) - FDA 510(k) Clearance

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

K212171 · Dongguan Kangweile Electronic Technology Co., Ltd. · Cardiovascular device
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Nov 2021
Decision
112d
Days
Class 2
Risk

K212171 is an FDA 510(k) clearance for the Electronic Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Dongguan Kangweile Electronic Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on November 1, 2021 after a review of 112 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 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 Dongguan Kangweile Electronic Technology Co., Ltd. devices

Submission Details

510(k) Number K212171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2021
Decision Date November 01, 2021
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
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 Consultant

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Reanny Wang

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 271
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K212171.
Arm Blood Pressure Monitor
K212877 · Alicn Medical (Shenzhen), Inc. · Jan 2022
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
K212115 · Joytech Healthcare Co. , Ltd. · Jan 2022
Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
K211288 · Microlife Intellectual Property GmbH · Nov 2021
Arm Blood Pressure Monitor
K210563 · Alicn Medical (Shenzhen), Inc. · Oct 2021
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
K210139 · Edan Instruments, Inc. · Oct 2021
Automatic Digital Blood Pressure Monitor
K210152 · Aviche Shandong Medical Technology Co, Ltd. · Sep 2021