# KXK: Source, Brachytherapy, Radionuclide

- Device class: 2; regulation: 21 CFR 892.5730; FDA's rule: 510(k) required
- FDA decisions: 151
- 510(k) review time 2021–2025: median 151 days (middle half 115–200)
- Recalls: 6 (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)
- 2014: 8
- 2015: 2
- 2016: 4
- 2017: 2
- 2018: 1
- 2019: 2
- 2020: 3
- 2022: 1
- 2023: 1
- 2025: 2

## Most-cited predicates
- K914281: I-125 Seeds, Code: 6711 (1991), cited by 12
- K010283: Theraseed (R) Palladium-103 Implant; Model 200 (2001), cited by 6
- K040339: Brachytherapy Strand Device (2004), cited by 5
- K010621: Accu-Space Absorbable Seeding Spacers (2001), cited by 5
- K972271: North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-a (1997), cited by 5
- K021343: Isoseeds I-125 (2002), cited by 4
- K030594: I-125 Rapid Strand, Model 7000 (2003), cited by 4
- K011155: Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031S (2001), cited by 3
- K013964: Modification to Accu-Space Plain Gut Absorbable Seeding Spacers (2002), cited by 3
- K030534: Variseed 7.1 (2003), cited by 3

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