# QSZ: Absorbable Synthetic Wound Dressing

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 22
- 510(k) review time 2021–2025: median 97 days (middle half 62–138)
- 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)
- 2015: 1
- 2016: 1
- 2017: 3
- 2018: 1
- 2020: 1
- 2022: 2
- 2023: 2
- 2024: 1
- 2025: 2
- 2026: 4

## Most-cited predicates
- K170300: Restrata Wound Matrix (2017), cited by 4
- K090160: Suprathel Wound and Burn Dressing (2009), cited by 4
- K132397: Gore Bio-a Wound Matrix (2014), cited by 3
- K172140: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (2017), cited by 2
- K222189: SiOxD Wound Matrix (2022), cited by 2
- K073251: Hyalomatrix PA (2007), cited by 2
- K031684: Topkin Wound Dressing (2003), cited by 1
- K221686: NovoSorb Matrix (2022), cited by 1
- K161067: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” (2016), cited by 1
- K193583: Restrata® (2020), cited by 1

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