Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iberhospitex, S.A. · 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) |
|---|---|---|---|---|---|
| K883982 | DRENOVAC | Iberhospitex, S.A. | 1989-02-23 | 156 | 0 |
| K883983 | SANIFIX | Iberhospitex, S.A. | 1988-12-13 | 84 | 0 |
| K881936 | OPER-FILM-ADHESIVE MEMBRANE | Iberhospitex, S.A. | 1988-08-31 | 114 | 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