Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OMR · Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
426 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111048 | SYNTHES SCOUT TACK FIXATION | Synthes Spine | 2012-06-14 | 426 | 0 |
| K111137 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | 2011-05-20 | 28 | 0 |
| K101805 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | 2011-04-08 | 284 | 0 |
| K103558 | SYNTHES SCOUT VESSEL GUARD | Synthes Spine | 2011-02-18 | 78 | 0 |
| K101826 | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 | Mimedx Group, Inc. | 2010-07-28 | 27 | 0 |
| K100984 | XYLOS VESSEL GUARD | Xylos Corporation | 2010-07-07 | 90 | 0 |
| K100905 | HYDROFIX SURGICAL SHEET | Mimedx Group, Inc. | 2010-06-02 | 62 | 0 |
| K093551 | PARADIS VASO SHIELD | Spinemedica, LLC | 2009-12-24 | 37 | 0 |
| K090022 | PARADIS VASO SHIELD | Spinemedica, LLC | 2009-04-20 | 105 | 0 |
| K082782 | REPLICATION MEDICAL VESSEL GUARD | Replication Medical, Inc. | 2009-04-02 | 192 | 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