Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Direx Systems Corp. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
207 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111947 | DUET MAGNA | Direx Systems Corp. | 2012-03-01 | 237 | 0 |
| K102765 | PRONEX | Direx Systems Corp. | 2010-12-07 | 74 | 0 |
| K072529 | TRACKPORT | Direx Systems Corp. | 2007-10-26 | 49 | 0 |
| K071701 | TRACKLEAF-10 | Direx Systems Corp. | 2007-07-23 | 32 | 0 |
| K063482 | CROSSPLAN / ACCUSOFT-XL V.4.04 | Direx Systems Corp. | 2006-12-14 | 27 | 0 |
| K062147 | INTEGRA SL | Direx Systems Corp. | 2006-10-20 | 85 | 0 |
| K062032 | ACCUSOFT, ACCUSOFT XL | Direx Systems Corp. | 2006-10-05 | 79 | 0 |
| K061873 | VERT-X | Direx Systems Corp. | 2006-08-18 | 46 | 0 |
| K061713 | MAGIS1;MAGIS2 | Direx Systems Corp. | 2006-07-21 | 32 | 0 |
| K052212 | MIGUE | Direx Systems Corp. | 2006-03-10 | 207 | 0 |
| K053640 | INTEGRA | Direx Systems Corp. | 2006-03-01 | 61 | 0 |
| K052705 | DART-12 | Direx Systems Corp. | 2006-02-21 | 146 | 0 |
| K043409 | ACCUCHANGER | Direx Systems Corp. | 2005-05-05 | 146 | 0 |
| K050091 | TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) | Direx Systems Corp. | 2005-03-16 | 61 | 0 |
| K041213 | 3DSCOPE | Direx Systems Corp. | 2004-07-22 | 73 | 0 |
| K041582 | MODIFICATION TO TRIPTER X-1 COMPACT DUET | Direx Systems Corp. | 2004-07-07 | 23 | 0 |
| K040474 | ACCUSOFT | Direx Systems Corp. | 2004-06-23 | 120 | 0 |
| K040470 | TRIPTER X-1 COMPACT | Direx Systems Corp. | 2004-04-28 | 64 | 0 |
| K040553 | MODIFICATION TO ACCULEAF | Direx Systems Corp. | 2004-04-01 | 30 | 0 |
| K032171 | ACCUSOFT | Direx Systems Corp. | 2003-12-15 | 152 | 0 |
| K023535 | TRIPTER X-1 COMPACT DUET | Direx Systems Corp. | 2003-01-17 | 88 | 0 |
| K021338 | ACCULEAF | Direx Systems Corp. | 2003-01-07 | 256 | 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