Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Keilei Intl., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
112 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913779 | BANDAGE ROLL, GAUZE | Keilei Intl., Inc. | 1991-12-04 | 112 | 0 |
| K912779 | GAUZE SPONGE,STERILE 2'S | Keilei Intl., Inc. | 1991-09-30 | 98 | 0 |
| K913575 | GAUZE PACKING, SURGICAL STERILE AND NON-STERILE | Keilei Intl., Inc. | 1991-09-06 | 25 | 0 |
| K895372 | X-RAY DETECTABLE GAUZE SPONGE | Keilei Intl., Inc. | 1989-11-03 | 66 | 0 |
| K895086 | GAUZE SPONGE | Keilei Intl., Inc. | 1989-10-23 | 76 | 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