Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Health Beacons, Inc. · 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) |
|---|---|---|---|---|---|
| K193189 | RFID Localization System | Health Beacons, Inc. | 2020-05-06 | 169 | 0 |
| K190932 | RFID Localization System | Health Beacons, Inc. | 2019-09-13 | 156 | 0 |
| K181692 | 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator | Health Beacons, Inc. | 2018-09-25 | 90 | 0 |
| K163667 | RFID Localization System- Localizer Reader, RFID Localizatio | Health Beacons, Inc. | 2017-04-28 | 122 | 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