Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osbon Medical Systems, Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912736 | ERECAID(R) SYSTEM PLUS | Osbon Medical Systems, Ltd. | 1991-08-12 | 52 | 0 |
| K901318 | STAYEREC SYSTEM(TM) | Osbon Medical Systems, Ltd. | 1990-05-04 | 44 | 0 |
| K895406 | OSBON PERSONAL LUBRICANT | Osbon Medical Systems, Ltd. | 1989-12-01 | 86 | 0 |
| K896207 | OSBON PERSONAL LUBRICANT | Osbon Medical Systems, Ltd. | 1989-12-01 | 36 | 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