# MJN: Catheter, Intravascular Occluding, Temporary

- Device class: 2; regulation: 21 CFR 870.4450; FDA's rule: 510(k) required
- FDA decisions: 90
- 510(k) review time 2021–2025: median 249 days (middle half 102–266)
- Recalls: 17 (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: 4
- 2016: 3
- 2017: 3
- 2018: 3
- 2019: 3
- 2020: 4
- 2021: 4
- 2022: 2
- 2023: 1
- 2025: 2

## Most-cited predicates
- K002286: Ldob Occlusion Balloon Catheter (2001), cited by 6
- K990487: Equinox Occlusion Balloon System (1999), cited by 6
- K011656: Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771 (2001), cited by 5
- K090728: Hyperglide Occlusion Balloon System (2009), cited by 4
- K021066: Modification to Hyperglide Occlusion Balloon System (2002), cited by 4
- K011526: Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 (2001), cited by 4
- K051067: Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port) (2005), cited by 4
- K140273: Equalizer Occlusion Balloon Catheter (2014), cited by 3
- K172790: ER-REBOA Catheter (2017), cited by 3
- K110741: Scepter C Occlusion Balloon Catheter (2011), cited by 3

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