# PZL: Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

- Device class: 2; regulation: 21 CFR 878.4685; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 206 days (middle half 110–208)
- 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
- 2019: 1
- 2020: 1
- 2021: 1
- 2023: 1
- 2024: 1
- 2025: 2

## Most-cited predicates
- K191961: OrthoGold (2019), cited by 3
- DEN160037: dermaPACE System (2017), cited by 2
- K231710: OW100S (2023), cited by 1
- K202112: Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (2021), cited by 1
- K200926: OrthoGold 100 (2020), cited by 1

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