Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imaging Biometrics, LLC — 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) |
|---|---|---|---|---|---|
| K201092 | LSN | Imaging Biometrics, LLC | 2020-10-29 | 189 | 0 |
| K191530 | StoneChecker | Imaging Biometrics, LLC | 2019-09-26 | 108 | 0 |
| K123302 | IB CLINIC | Imaging Biometrics, LLC | 2013-01-11 | 80 | 0 |
| K080762 | IB NEURO, VERSION 1.0 | Imaging Biometrics, LLC | 2008-05-15 | 58 | 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