Cleared Special

Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)

K242721 · Shenzhen Finicare Co., Ltd. · Cardiovascular
Oct 2024
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K242721 is an FDA 510(k) clearance for the Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Shenzhen Finicare Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 4, 2024, 24 days after receiving the submission on September 10, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K242721 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2024
Decision Date October 04, 2024
Days to Decision 24 days
Submission Type Special
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

More from Shenzhen Finicare Co., Ltd.

View all
Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)
K252769 · DXN · Oct 2025
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
K243136 · FLL · Feb 2025
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
K231367 · DXN · Sep 2023
Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)
K220113 · DXN · May 2022
Infrared Thermometer
K181215 · FLL · Jan 2019