Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Parallax Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
279 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 |
| K023445 | TRACERS BONE CEMENT OPACIFIER | Parallax Medical, Inc. | 2003-03-11 | 147 | 0 |
| K022169 | CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES | Parallax Medical, Inc. | 2002-07-25 | 22 | 0 |
| K011206 | PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES | Parallax Medical, Inc. | 2001-07-18 | 90 | 0 |
| K994022 | PARALLAX CRANIOSET | Parallax Medical, Inc. | 2000-08-31 | 279 | 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