# K222010: Biobeat Platform-2 and BB-613WP Patch

- Pathway: 510(k) (Traditional)
- Applicant: Biobeat Technologies, Ltd.
- Decided: Dec 30, 2022 after 176 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K962603 (1997). 177 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212153: Biobeat Platform, BB-613WP Patch, Biobeat Technologies, Ltd. (2022) Summary page 4.
- K182245: EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System, Edwards Lifesciences, LLC (2018) Summary page 4.

## Most influential descendants
- K241066: BB-613-BPM (2025), 0 descendants of its own

## Indications for use
The Biobeat Platform-2 is a wireless noninvasive remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, blood pressure, respiration rate (RRp), hemodynamic parameters (stroke volume, cardiac output), and body temperature. The Biobeat Platform-2 tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. The Biobeat Platform-2 is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. The data from the Biobeat Platform-2 are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K222010
Methodology: https://510kreport.com/methodology