Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neostar Medical Technologies, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960625 | SPREADABLE SHEATH INTRODUCER SET | Neostar Medical Technologies, Inc. | 1996-08-08 | 177 | 0 |
| K941851 | DUAL LUMEN CATHETER (DLC) TRAY | Neostar Medical Technologies, Inc. | 1995-03-13 | 333 | 1 |
| K944511 | ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC) | Neostar Medical Technologies, Inc. | 1995-03-13 | 179 | 0 |
| K944660 | ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY | Neostar Medical Technologies, Inc. | 1995-03-13 | 173 | 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