Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biobeat Technologies , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241066 | BB-613-BPM | Biobeat Technologies , Ltd. | 2025-01-14 | 271 | 0 |
| K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies , Ltd. | 2022-12-30 | 176 | 0 |
| K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies , Ltd. | 2022-03-25 | 259 | 0 |
| K190792 | BB-613WP | Biobeat Technologies , Ltd. | 2019-08-22 | 148 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda