FDA applicant
Biobeat Technologies, Ltd.
FDA records 4 decisions for Biobeat Technologies, Ltd. (Petah Tikvah, IL) from 2019 to 2025: 4 510(k) clearances. Most are in product codes DQA (Oximeter) and DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 218 days from receipt to decision, against 212 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biobeat Technologies, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Biobeat Technologies, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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