Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lsi Intl., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
238 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002390 | QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H | Lsi Intl., Inc. | 2000-11-02 | 90 | 0 |
| K984021 | MS300 | Lsi Intl., Inc. | 1999-01-28 | 77 | 0 |
| K984113 | MS400 | Lsi Intl., Inc. | 1999-01-28 | 72 | 0 |
| K970696 | S.P. 100 | Lsi Intl., Inc. | 1997-03-18 | 21 | 0 |
| K933653 | MS 2500 | Lsi Intl., Inc. | 1994-03-23 | 238 | 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