# K181006: BB-613 Watch Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Beat Technologies, Ltd.
- Decided: Sep 21, 2018 after 158 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: 5 generations back to K001085 (2000). 5 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163382: Oxitone 1000, Oxitone Medical, Ltd. (2017) Summary page 4.

## Most influential descendants
- K190792: BB-613WP (2019), 12 descendants of its own
- 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

## Indications for use
The BB-613 Watch Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.

Source page: https://510kreport.com/device/K181006
Methodology: https://510kreport.com/methodology