Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laivan Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
244 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923815 | TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS | Laivan Corp. | 1993-03-31 | 244 | 0 |
| K890940 | MODIFIED LABELING FOR POLYDERM WBC(TM) | Laivan Corp. | 1989-04-17 | 54 | 0 |
| K885205 | AQUADERM | Laivan Corp. | 1989-03-29 | 100 | 0 |
| K880153 | POLYDERM A+B(TM) | Laivan Corp. | 1988-04-13 | 91 | 0 |
| K880964 | POLYDERM PEC(TM), POROUS ELASTIC COVER | Laivan Corp. | 1988-03-17 | 9 | 0 |
| K880206 | POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER | Laivan Corp. | 1988-03-11 | 56 | 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