Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LWE · 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) |
|---|---|---|---|---|---|
| K952350 | JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE | Promedical , Ltd. | 1995-07-17 | 59 | 0 |
| K913306 | BONE-TEMNO/STERNUM-TEMNO | Proact, Ltd. | 1991-11-01 | 99 | 1 |
| K871198 | BONE MARROW COLLECTION KIT AND STAND | Baxter Healthcare Corp | 1987-11-06 | 227 | 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