Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Std Mfg., Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
204 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023096 | CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACIN | Std Mfg., Inc. | 2003-04-10 | 204 | 5 |
| K021549 | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACIN | Std Mfg., Inc. | 2002-08-01 | 80 | 0 |
| K012362 | MODIFICATION TO VASCULAR CLOSURE DEVICE | Std Mfg., Inc. | 2001-08-23 | 29 | 0 |
| K003169 | VASCULAR CLOSURE DEVICE | Std Mfg., Inc. | 2000-12-08 | 59 | 0 |
| K000608 | SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM | Std Mfg., Inc. | 2000-03-07 | 13 | 0 |
| K930427 | STD IRRIGATION PUMP | Std Mfg., Inc. | 1993-06-01 | 126 | 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