# PKP: Immunoglobulin G (Igg) Infusion System

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 167 days (middle half 75–246)
- Recalls: 0 (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: 1
- 2016: 1
- 2018: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K222087: SCIg60 Infusion System (2022), cited by 2
- K161906: SCIg60 Infuser (2016), cited by 2
- K142319: SCIg60 Infuser, Infuset (2015), cited by 1
- K240148: SCIg60 Infusion System (2024), cited by 1

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