# Biobeat Technologies, Ltd.

- Location (FDA's records): Petah Tikvah, IL
- FDA decisions: 4 (2019–2025): 4 510(k) clearances
- Product codes: DQA (3), DXN (1)
- 510(k) review time since 2016: median 218 days, against 212 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 8 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- Vitalconnect, Inc.: 1 (https://510kreport.com/company/vitalconnect)
- Bio-Beat Technologies, Ltd.: 1 (https://510kreport.com/company/bio-beat-technologies)
- Athena Gtx: 1 (https://510kreport.com/company/athena-gtx)
- Healthstats International Pte., Ltd.: 1 (https://510kreport.com/company/healthstats-international)
- Caretaker Medical, LLC: 1 (https://510kreport.com/company/caretaker-medical)

## Firms that cite its devices most
- Lifesignals, Inc.: 1 (https://510kreport.com/company/lifesignals)
- Aktiia SA: 1 (https://510kreport.com/company/aktiia)
- Accurate Meditech, Inc.: 1 (https://510kreport.com/company/accurate-meditech)
- Nanowear, Inc.: 1 (https://510kreport.com/company/nanowear)

## Its most-cited devices
- K190792: BB-613WP (2019), cited by 5
- K212153: Biobeat Platform, BB-613WP Patch (2022), cited by 2
- K222010: Biobeat Platform-2 and BB-613WP Patch (2022), cited by 1

## Recent decisions
- K241066: BB-613-BPM (Jan 14, 2025)
- K222010: Biobeat Platform-2 and BB-613WP Patch (Dec 30, 2022)
- K212153: Biobeat Platform, BB-613WP Patch (Mar 25, 2022)
- K190792: BB-613WP (Aug 22, 2019)

Source page: https://510kreport.com/company/biobeat-technologies