Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lsi Solutions, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
294 daysmedian FDA review time
484 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN230069 | Mi-CHORD System | Lsi Solutions, Inc. | 2024-06-11 | 256 | 0 |
| K222783 | MD Mattress Suture Placement Device | Lsi Solutions, Inc. | 2024-01-12 | 484 | 0 |
| K202551 | Cor-Knot Micro | Lsi Solutions, Inc. | 2021-06-24 | 294 | 0 |
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 | Lsi Solutions, Inc. | 2020-11-24 | 39 | 0 |
| K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESS | Lsi Solutions, Inc. | 2012-07-13 | 459 | 0 |
| K100593 | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLA | Lsi Solutions, Inc. | 2010-10-13 | 225 | 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