Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lysonix, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
136 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980771 | LYSONIX SUCTION LIPOPLASTY SYSTEM | Lysonix, Inc. | 1998-07-13 | 136 | 0 |
| K980763 | LYSONIX LIPOPLASTY ACCESS PORT | Lysonix, Inc. | 1998-05-28 | 90 | 0 |
| K980454 | LYSONIX ASPIRATION PUMP | Lysonix, Inc. | 1998-03-18 | 41 | 0 |
| K974233 | LYSONIX IRRIGATION SYSTEM | Lysonix, Inc. | 1998-02-03 | 83 | 0 |
| K972958 | LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSO | Lysonix, Inc. | 1997-09-19 | 39 | 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