Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ostex Intl., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
154 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011052 | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE | Ostex Intl., Inc. | 2001-07-30 | 115 | 0 |
| K983457 | OSTEOMARK NTX SERUM EIA | Ostex Intl., Inc. | 1999-02-02 | 125 | 0 |
| K980518 | OSTEOMARK | Ostex Intl., Inc. | 1998-03-06 | 49 | 0 |
| K961562 | OSTEOMARK | Ostex Intl., Inc. | 1996-07-11 | 80 | 0 |
| K945946 | OSTEOMARK(R) | Ostex Intl., Inc. | 1995-05-08 | 154 | 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