# KRD: Device, Vascular, For Promoting Embolization

- Device class: 2; regulation: 21 CFR 870.3300; FDA's rule: 510(k) required
- FDA decisions: 134
- 510(k) review time 2021–2025: median 105 days (middle half 47–180)
- Recalls: 7 (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: 4
- 2018: 4
- 2019: 6
- 2020: 4
- 2021: 3
- 2022: 8
- 2023: 2
- 2024: 6
- 2025: 9
- 2026: 7

## Most-cited predicates
- K071939: Hydrocoil Embolic Systems (Hes) (2008), cited by 6
- K955293: Fibered Platinum Coil, .035 Type (1996), cited by 6
- K081465: Axium Detachable Coil System (2008), cited by 5
- K914786: Target Therapeutics Coils (1992), cited by 5
- K123803: Reverse Medical Micro Vascular Plug (MVP) System (2013), cited by 4
- K073417: Embozene Microspheres (2008), cited by 4
- K031810: Amplatzer Vascular Plug (2003), cited by 4
- K113658: Amplatzer Vascular Plug 4 (2012), cited by 4
- K183120: EmboCube Embolization Gelatin (2019), cited by 3
- K083091: LC Bead Microspheres, Bead Block Compressible Microspheres (2008), cited by 3

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