Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laurus Medical Corp. — 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) |
|---|---|---|---|---|---|
| K973415 | CURVILINEAR SUTURE PLACEMENT SYSTEM | Laurus Medical Corp. | 1997-12-02 | 84 | 0 |
| K973215 | STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM | Laurus Medical Corp. | 1997-11-06 | 71 | 0 |
| K960317 | LAURUS NEEDLE CORE BIOPSY SYSTEM | Laurus Medical Corp. | 1996-03-15 | 52 | 0 |
| K932553 | DISPOSABLE SUTURE PLACEMENT SYSTEM | Laurus Medical Corp. | 1994-05-12 | 351 | 2 |
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