Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QSX — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
44 daysmedian FDA review time
184 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200720 | D-Stat Radial Topical Hemostat | Vascular Solutions, LLC | 2020-06-26 | 99 | 0 |
| K102212 | D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP | Vascular Solutions, Inc. | 2011-04-08 | 245 | 0 |
| K092612 | D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 | Vascular Solutions, Inc. | 2009-09-11 | 16 | 0 |
| K083190 | D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 | Vascular Solutions, Inc. | 2008-11-12 | 14 | 0 |
| K073264 | D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 | Vascular Solutions, Inc. | 2007-12-07 | 17 | 0 |
| K072117 | THROMBIX PATCH THROMBIN HEMOSTASIS PATCH | Vascular Solutions, Inc. | 2007-10-05 | 65 | 0 |
| K070938 | THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT | Vascular Solutions, Inc. | 2007-08-06 | 124 | 0 |
| K063860 | THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT | Vascular Solutions, Inc. | 2007-02-13 | 47 | 0 |
| K061219 | D-STAT DRY HEMOSTATIC BANDAGE | Vascular Solutions, Inc. | 2006-10-06 | 158 | 0 |
| K053644 | THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT | Vascular Solutions, Inc. | 2006-02-09 | 41 | 0 |
| K053054 | THROMBIX 3X3 HEMOSTATIC PAD | Vascular Solutions, Inc. | 2005-11-23 | 23 | 0 |
| K050511 | THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT | Vascular Solutions, Inc. | 2005-04-14 | 44 | 0 |
| K050133 | D-STAT RADIAL HEMOSTATIC BAND | Vascular Solutions, Inc. | 2005-02-18 | 28 | 0 |
| K040510 | VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD | Vascular Solutions, Inc. | 2004-03-17 | 19 | 0 |
| K040118 | VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT | Vascular Solutions, Inc. | 2004-02-12 | 23 | 0 |
| K033709 | VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE | Vascular Solutions, Inc. | 2003-12-18 | 22 | 1 |
| K030836 | D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BAND | Vascular Solutions, Inc. | 2003-09-17 | 184 | 3 |
| K012293 | VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT | Vascular Solutions, Inc. | 2002-01-18 | 182 | 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