# KDJ: Set, Administration, For Peritoneal Dialysis, Disposable

- Device class: 2; regulation: 21 CFR 876.5630; FDA's rule: 510(k) required
- FDA decisions: 113
- 510(k) review time 2021–2025: median 86 days (middle half 68–175)
- Recalls: 41 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 2
- 2008: 1
- 2013: 1
- 2015: 2
- 2016: 1
- 2018: 3
- 2019: 1
- 2022: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K895631: Disconnect Caps Product Codes 5C4212 and 5C4466 (1990), cited by 3
- K972579: High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with Povidone-Iodine (1997), cited by 2
- K895991: Peritoneal Dialysis Drainage Set NO. 48-0025-6 (1990), cited by 2
- K883239: Capd Ultraviolet (U.V.) Germicidal Exchange Dev Sys (1988), cited by 2
- K896764: Universal Connector Catalog NO. 48-1025-5 (1990), cited by 2
- K152675: Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter Adapter (2015), cited by 2
- K921818: Abbott Smart Cap (1994), cited by 1
- K945567: QC CAP (1995), cited by 1
- K900106: Closed Disconnect System (1990), cited by 1
- K022412: Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe Connector (2003), cited by 1

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