BB-613-BPM

FDA 510(k) K241066 · Biobeat Technologies , Ltd.

Substantially Equivalent

510(k) numberK241066

Submission

Device name
BB-613-BPM
Applicant
Biobeat Technologies , Ltd.
Petah Tikvah, IL
Received
April 18, 2024
Decision date
January 14, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXN – System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1130
Specialty
Cardiovascular

Other 510(k)s with product code DXN

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K261929Upper Arm Blood pressure monitor (BP7155D)DXN · Special OMRON Healthcare, Inc.09/10/2026SE
K254000Happy Health Blood Pressure MonitorDXN · Traditional Happy Health, Inc.09/03/2026SE
K262658Automatic Digital Blood Pressure monitor (LD-526)DXN · Special Honsun (Nantong) Co., Ltd.08/31/2026SE
K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional JOYTECH Healthcare Co., Ltd.08/26/2026SE
K261061BP Go (BPP-855)DXN · Traditional Wellvii, Inc.08/13/2026SE
K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional Joytech Healthcare Co. , Ltd.08/13/2026SE
K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional Guangzhou Daxin Health Technology Co., Ltd.07/23/2026SE
K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional Microlife Corporation07/23/2026SE
K253126Wrist Blood Pressure Monitor (XW-05)DXN · Traditional Shenzhen Ziqing Medical Equipment Co., Ltd.06/18/2026SE
K260693VicorderCS (VCS-SYS-1100)DXN · Traditional 80 Beats Medical GmbH06/16/2026SE

More from 80 Beats Medical GmbH

510(k)DeviceDecision
K222010Biobeat Platform-2 and BB-613WP PatchDQA · Traditional 12/30/2022SE
K212153Biobeat Platform, BB-613WP PatchDQA · Traditional 03/25/2022SE
K190792BB-613WPDQA · Traditional 08/22/2019SE

Questions and answers

When was BB-613-BPM cleared by the FDA?

BB-613-BPM (K241066) received a 510(k) decision of Substantially Equivalent on January 14, 2025, 271 days after the submission was received.

What is the product code of K241066?

The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.