# K190792: BB-613WP

- Pathway: 510(k) (Traditional)
- Applicant: Biobeat Technologies, Ltd.
- Decided: Aug 22, 2019 after 148 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: 10 generations back to K962603 (1997). 74 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181006: BB-613 Watch Oximeter, Bio-Beat Technologies, Ltd. (2018) Summary page 4.
- K113165: Mini-Medic, Athena Gtx (2012) Summary page 4.
- K173028: BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software, Healthstats International Pte., Ltd. (2018) Summary page 4.
- K163255: CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor, Caretaker Medical, LLC (2017) Summary page 4.

## Most influential descendants
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own
- K222658: Accurate 24 Non-invasive blood pressure monitor (2023), 2 descendants of its own
- K250415: G0 Blood Pressure Monitoring System (G0) (2025), 1 descendant of its own
- K222010: Biobeat Platform-2 and BB-613WP Patch (2022), 1 descendant of its own

## Indications for use
The BB-613 WP is a wrist-worn or skin attached device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. The BB-613WP can also track 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 oscillometric blood pressure monitor. The BB-613WP is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.

Source page: https://510kreport.com/device/K190792
Methodology: https://510kreport.com/methodology