Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Haolang Medical USA Corporation · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | 2025-05-16 | 347 | 0 |
| K201726 | Arterial Catheter | Haolang Medical USA Corporation | 2021-07-07 | 379 | 0 |
| K201697 | Umbilical Vessels Catheter | Haolang Medical USA Corporation | 2021-05-06 | 318 | 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