# K212153: Biobeat Platform, BB-613WP Patch

- Pathway: 510(k) (Traditional)
- Applicant: Biobeat Technologies, Ltd.
- Decided: Mar 25, 2022 after 259 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: 20 generations back to K962603 (1997). 165 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 171 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190792: BB-613WP, Biobeat Technologies, Ltd. (2019) Summary page 4.
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter, Masimo Corporation (2019) Summary page 4.
- K183078: VitalConnect Platform, VitalPatch Biosensor, Vitalconnect, Inc. (2019) Summary page 4.

## Most influential descendants
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own
- K222010: Biobeat Platform-2 and BB-613WP Patch (2022), 1 descendant of its own
- K260157: LifeLens Physiological Monitor (2026), 0 descendants of its own
- K252984: Perin Health System (PHD80060-2) (2026), 0 descendants of its own
- K241066: BB-613-BPM (2025), 0 descendants of its own

## Indications for use
The Biobeat Platform 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 (%Sp02), pulse rate, blood pressure, respiration rate (RRp), and body temperature. The Biobeat Platform 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 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 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/K212153
Methodology: https://510kreport.com/methodology