# LJS: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

- Device class: 2; regulation: 21 CFR 880.5970; FDA's rule: 510(k) required
- FDA decisions: 303
- 510(k) review time 2021–2025: median 179 days (middle half 70–234)
- Recalls: 168 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 9
- 2017: 7
- 2018: 10
- 2020: 2
- 2021: 3
- 2022: 3
- 2023: 4
- 2024: 1
- 2025: 8
- 2026: 2

## Most-cited predicates
- K053501: Powerpicc (2006), cited by 12
- K033389: Powerpicc Catheters, Models 3175155, 3175135 (2004), cited by 11
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line (2005), cited by 10
- K051672: Powerpicc (2005), cited by 9
- K091953: Pro-Picc (2009), cited by 8
- K053345: Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D (2006), cited by 7
- K070002: Boston Scientific Peripherally Inserted Central Catheter (2007), cited by 7
- K121089: Nmi Picc Iii (2012), cited by 6
- K034019: Poly Per-Q-Cath Picc Catheters (2004), cited by 6
- K072625: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) (2007), cited by 6

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