Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
L&Z Us, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
275 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233149 | CATHTONG III Tapered PICC Catheter | L&Z Us, Inc. | 2023-12-01 | 65 | 0 |
| K232571 | CATHTONG™ II PICC Catheter | L&Z Us, Inc. | 2023-09-22 | 29 | 0 |
| K232594 | CATHTONG™ II PICC Catheter | L&Z Us, Inc. | 2023-09-22 | 28 | 0 |
| K172039 | CATHTONG II PICC Catheter | L&Z Us, Inc. | 2017-08-03 | 29 | 0 |
| K170486 | CATHTONG II PICC Catheter | L&Z Us, Inc. | 2017-05-25 | 101 | 0 |
| K153469 | Cathtong I PICC Catheter | L&Z Us, Inc. | 2016-09-01 | 275 | 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