Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgipro, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
184 daysmedian FDA review time
751 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934031 | STERILE CENTRAL LINE DRESSING TRAY | Surgipro, Inc. | 1994-03-01 | 196 | 0 |
| K934028 | STERILE DRESSING CHANGE TRAY | Surgipro, Inc. | 1994-02-17 | 184 | 0 |
| K934029 | STERILE LACERATION & DEBRIDEMENT TRAYS | Surgipro, Inc. | 1994-02-04 | 171 | 0 |
| K934030 | STERILE TRACHEOSTOMY TRAY | Surgipro, Inc. | 1994-01-26 | 162 | 0 |
| K912351 | VARIOUS STERILE CUSTOM DRESSING TRAYS & KITS | Surgipro, Inc. | 1993-06-17 | 751 | 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