Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Opportunity, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
176 daysmedian FDA review time
176 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971091 | OPPURTUNITY TRACHEOSTOMY CARE KIT | Opportunity, Inc. | 1997-09-16 | 176 | 0 |
| K971093 | OPPORTUNITY I.V. START KIT | Opportunity, Inc. | 1997-09-16 | 176 | 0 |
| K971095 | OPPORTUNITY SUTURE REMOVAL KIT | Opportunity, Inc. | 1997-09-16 | 176 | 0 |
| K971089 | OPPORTUNITY, INC. LACERATION TRAY | Opportunity, Inc. | 1997-09-16 | 176 | 0 |
| K971088 | OPPORTUNITY INCISION AND DRAINAGE TRAY | Opportunity, Inc. | 1997-09-16 | 176 | 0 |
| K971090 | OPPORTUNITY DRESSING CHANGE TRAY | Opportunity, Inc. | 1997-09-16 | 176 | 0 |
| K971061 | OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY | Opportunity, Inc. | 1997-06-11 | 79 | 0 |
| K971062 | OPPORTUNITY INC. GENERAL PURPOSE TRAY | Opportunity, Inc. | 1997-06-09 | 77 | 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