Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sea-Pac Trading Corp. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
25 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K770541 | SCISSORS, SURGICAL, 12.5,14,16 & 18 CM. | Sea-Pac Trading Corp. | 1977-04-15 | 25 | 0 |
| K770544 | SCISSORS, BANDAGE, 15,18,20CM., ANGULAR | Sea-Pac Trading Corp. | 1977-04-15 | 25 | 0 |
| K770538 | FORCEPS, HAEMOSTATIC, 14 16,&18 CM. LONG | Sea-Pac Trading Corp. | 1977-04-15 | 25 | 0 |
| K770540 | FORCEPS, MOSQUITO STYLE, 12.5 CM. | Sea-Pac Trading Corp. | 1977-04-15 | 25 | 0 |
| K770542 | SCISSORS, MAYO _TYLE, 14,16,18,20,22 CM. | Sea-Pac Trading Corp. | 1977-04-15 | 25 | 0 |
| K770539 | FORCEPS, HAEM, DEEP OPERATION, 20&22 CM. | Sea-Pac Trading Corp. | 1977-04-15 | 25 | 0 |
| K770543 | SCISSORS, SURGICAL, ANGULAR, 14 CM. | Sea-Pac Trading Corp. | 1977-04-15 | 25 | 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