Cleared Traditional

K202934 - Blood Pressure Monitor

K202934 is an FDA 510(k) clearance for Blood Pressure Monitor, manufactured by Bioland Technology, Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K202934 · Bioland Technology, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
119d
Days
Class 2
Risk

K202934 is an FDA 510(k) clearance for the Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Bioland Technology, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 26, 2021 after a review of 119 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 Bioland Technology, Ltd. devices

FDA 510(k) Submission Details - K202934

510(k) Number K202934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2020
Decision Date January 26, 2021
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 566
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K202934.
Meditech ABPM-06 (BP6)
K201332 · Meditech , Ltd. · Feb 2021
Wrist Electronic Sphygmomanometer
K193386 · Shenzhen Changkun Technology Co., Ltd. · Jan 2021
Arm Electronic Sphygmomanometer
K193387 · Shenzhen Changkun Technology Co., Ltd. · Jan 2021
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
K203131 · Edwards Lifesciences, LLC · Jan 2021
InBody
K200560 · Inbody Co., Ltd. · Jan 2021
Upper Arm Electronic Blood Pressure Monitor
K202372 · Conmo Electronic Company Limited · Dec 2020