Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LXG — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021927 | PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SY | Biomet, Inc. | 2002-07-12 | 30 | 0 |
| K943466 | MINI S.F.T. (URINE PRESERVATIVE) | Cambridge Diagnostic Products, Inc. | 1995-05-24 | 343 | 0 |
| K896802 | MAGNET PAD | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 | 26 | 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