# QSX: Hemostatic Wound Dressing With Thrombin Or Other Biologics

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 18
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2002: 1
- 2003: 2
- 2004: 2
- 2005: 3
- 2006: 2
- 2007: 4
- 2008: 1
- 2009: 1
- 2011: 1
- 2020: 1

## Most-cited predicates
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage (2003), cited by 8
- K061219: D-Stat Dry Hemostatic Bandage (2006), cited by 4
- K050511: Thrombigel Thrombin/Gelatin Foam Hemostat (2005), cited by 4
- K073264: D-Stat Dry Clear Hemostatic Bandage, Model 3005 (2007), cited by 3
- K072117: Thrombix Patch Thrombin Hemostasis Patch (2007), cited by 2
- K050133: D-Stat Radial Hemostatic Band (2005), cited by 2
- K012293: Vascular Solutions Duett Flowable Hemostat (2002), cited by 2
- K040510: Vascular Solutions D-Stat Dry 3X3 Hemostatic Pad (2004), cited by 2
- K063860: Thrombigel Thrombin/Gelatin Foam Hemostat (2007), cited by 2
- K033709: Vascular Solutions D-Stat 2 Dry Hemostatic Bandage (2003), cited by 1

Source page: https://510kreport.com/product-code/QSX
Data by year (CSV): https://510kreport.com/product-code/QSX.csv