Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pacific Materials and Interfaces — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983360 | MACROPORE PROTECTIVE SHEET | Pacific Materials and Interfaces | 1999-03-19 | 176 | 0 |
| K972913 | MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM) | Pacific Materials and Interfaces | 1998-07-30 | 357 | 0 |
| K972327 | METAGEN ACTIVELOCK CERCLAGE SYSTEM | Pacific Materials and Interfaces | 1997-08-11 | 49 | 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