# FKX: System, Peritoneal, Automatic Delivery

- Device class: 2; regulation: 21 CFR 876.5630; FDA's rule: 510(k) required
- FDA decisions: 83
- 510(k) review time 2021–2025: median 211 days (middle half 177–241)
- Recalls: 37 (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)
- 2006: 1
- 2011: 2
- 2013: 2
- 2014: 1
- 2015: 1
- 2017: 1
- 2018: 2
- 2020: 1
- 2022: 4
- 2025: 2

## Most-cited predicates
- K923065: Baxter Personal Cycler Autommated Peritoneal Dial (1994), cited by 6
- K012988: Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469 (2001), cited by 5
- K043363: Fresenius Liberty Cycler (2005), cited by 4
- K181108: Fresenius Liberty Select Cycler (2018), cited by 3
- K823331: PC-204 Tunnelor (1983), cited by 3
- K002892: Frsenius PD Iqcard Cycler (2001), cited by 2
- K141145: Liberty PDX Cycler (2014), cited by 2
- K053512: Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and 5C8310 (2006), cited by 2
- K123630: Fresenius Liberty Cycler (2013), cited by 2
- K811986: The Amp 80/2 Pediatric Cycler System (1981), cited by 1

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