# QSY: Hemostatic Wound Dressing Without Thrombin Or Other Biologics

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 127
- 510(k) review time 2021–2025: median 231 days (middle half 152–382)
- 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)
- 2017: 1
- 2018: 5
- 2019: 4
- 2020: 1
- 2021: 1
- 2022: 2
- 2023: 7
- 2024: 4
- 2025: 2
- 2026: 2

## Most-cited predicates
- K013390: Quickclot (2002), cited by 8
- K072474: Quikclot EX (2007), cited by 8
- K032986: Clo-Surplusp.a.D. (2004), cited by 7
- K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266 (2009), cited by 7
- K061079: Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762 Hemostatic Granules (2006), cited by 7
- K080097: Medtrade Products Celox Hemostatic Granules on Sheet (2008), cited by 6
- K010933: Seal-on Topical Hempstatic Powder Spray (2002), cited by 6
- K043050: Hemcon Bandage and Hemcon Bandage Otc (2005), cited by 6
- K072681: Bloodstop Hemostatic Gauze; IX Hemostatic Gauze (2007), cited by 5
- K021062: Chito-Seal (2002), cited by 5

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