Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MYU · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
221 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033230 | TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA | Parallax Medical, Inc. | 2003-12-12 | 67 | 0 |
| K032388 | BONE CEMENT RADIO-OPACIFIER | Cardinalhealth | 2003-10-31 | 88 | 0 |
| K024359 | VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 | Vista Scientific, LLC | 2003-08-08 | 221 | 0 |
| K023445 | TRACERS BONE CEMENT OPACIFIER | Parallax Medical, Inc. | 2003-03-11 | 147 | 0 |
| K002063 | BIOTRACE, MODEL 1730 | Bryan Corp. | 2000-08-10 | 34 | 0 |
| K991893 | PARALLAX TRACER RADIOPAQUE PARTICLES | Parallax Medical, Inc. | 1999-08-13 | 71 | 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