Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C.I.S.A. Import Export C/O Larson and Taylor · 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) |
|---|---|---|---|---|---|
| K880587 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 | C.I.S.A. Import Export C/O Larson and Taylor | 1988-12-20 | 313 | 0 |
| K880586 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2 | C.I.S.A. Import Export C/O Larson and Taylor | 1988-12-20 | 313 | 0 |
| K880588 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 | C.I.S.A. Import Export C/O Larson and Taylor | 1988-12-20 | 313 | 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