Cleared Traditional

Blood Pressure Monitor

K233130 · Guangdong Transtek Medical Electronics Co., Ltd. · Cardiovascular
Dec 2023
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K233130 is an FDA 510(k) clearance for the Blood Pressure Monitor, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Guangdong Transtek Medical Electronics Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on December 20, 2023, 84 days after receiving the submission on September 27, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K233130 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date December 20, 2023
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

Similar Devices — DXN System, Measurement, Blood-pressure, Non-invasive

All 1203
YUWELL? Electronic Blood Pressure Monitor (YE630CR)
K252779 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Mar 2026
YUWELL? Electronic Blood Pressure Monitor (YE650AR)
K253228 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Wrist Blood Pressure Monitor (BPM-W1VL)
K253133 · Shenzhen Imdk Medical Technology Co., Ltd. · Feb 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
K252685 · Joytech Healthcare Co. , Ltd. · Feb 2026
Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
K251581 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Feb 2026
Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
K251307 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Jan 2026