# K241066: BB-613-BPM

- Pathway: 510(k) (Traditional)
- Applicant: Biobeat Technologies, Ltd.
- Decided: Jan 14, 2025 after 271 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K962603 (1997). 178 ancestors in all.
No later device cites it as a predicate yet.
2 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190792: BB-613WP, Biobeat Technologies, Ltd. (2019) Summary page 5.
- K222010: Biobeat Platform-2 and BB-613WP Patch, Biobeat Technologies, Ltd. (2022) Summary page 5.

## Indications for use
The Biobeat BB-613-BPM is a noninvasive blood pressure monitor which provides a notification to the user every 15 minutes over a 24 hour period for user- initiated measurements. It includes a device and a platform (BPM) for use in adults by healthcare professionals, for collection of pulse rate and tracking changes in blood pressure based on Pulse Wave Transit Time (PWTT) in hospitals, clinics, long-term care and at home. The BB-613-BPM tracks changes in blood pressure and requires calibration using an FDA-cleared oscillometric blood pressure monitor. The data from the Biobeat BB-613-BPM can be accessed through the Biobeat platform for review by a healthcare professional or can be downloaded as a report. The device is not intended to be used on critical care patients.

Source page: https://510kreport.com/device/K241066
Methodology: https://510kreport.com/methodology