Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lsi Solutions — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
161 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK | Lsi Solutions | 2020-11-24 | 42 | 0 |
| K163639 | LS-5 ePTFE Suture | Lsi Solutions | 2017-06-02 | 161 | 0 |
| K040232 | LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PR | Lsi Solutions | 2004-03-01 | 28 | 0 |
| K031443 | LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS | Lsi Solutions | 2003-06-18 | 43 | 0 |
| K024301 | LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PR | Lsi Solutions | 2003-03-24 | 90 | 0 |
| K011016 | LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORI | Lsi Solutions | 2001-04-27 | 23 | 1 |
| K981531 | SUTURE PLACEMENT DEVICE AND ACCESSORIES | Lsi Solutions | 1998-07-13 | 75 | 0 |
| K963919 | LSI VIDEOSCOPIC DISPLAY SYSTEM | Lsi Solutions | 1997-01-08 | 100 | 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