# LJT: Port & Catheter, Implanted, Subcutaneous, Intravascular

- Device class: 2; regulation: 21 CFR 880.5965; FDA's rule: 510(k) required
- FDA decisions: 288
- 510(k) review time 2021–2025: median 71 days (middle half 49–88)
- Recalls: 85 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 7
- 2014: 2
- 2015: 4
- 2016: 3
- 2019: 1
- 2020: 1
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple (2006), cited by 19
- K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached) (2007), cited by 8
- K063377: Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter (2007), cited by 8
- K873213: Hickman Plastic Subcutaneous Port (1987), cited by 6
- K932840: Port-a-Cath Implantable Vascular Access System (1994), cited by 5
- K942024: Port-a-Cath Low Profile Implantable Venous Access System (1994), cited by 5
- K880571: Cath-Tech Port Implantable Vascular Access System (1988), cited by 4
- K122899: Powerport Clearvue Slim Implantable Port (2012), cited by 4
- K952548: Celsite Venous System (1995), cited by 4
- K003006: Two-Lumen Picc with Blue Flextip Catheter and Integral Needle Protection (2000), cited by 3

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