# KOC: Accessories, Blood Circuit, Hemodialysis

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 182
- 510(k) review time 2021–2025: median 190 days (middle half 98–274)
- Recalls: 14 (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)
- 2008: 2
- 2009: 2
- 2012: 1
- 2014: 1
- 2015: 2
- 2016: 1
- 2017: 1
- 2020: 1
- 2023: 2
- 2025: 2

## Most-cited predicates
- K201207: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line (2020), cited by 3
- K082719: Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-P (2009), cited by 3
- K911315: Extracorporeal Blood Pumping Syst for Hemofiltrat (1991), cited by 3
- K230514: Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series (2023), cited by 2
- K172238: CAREline Airless Hemodialysis Blood Tubing Sets (2017), cited by 2
- K081740: Hemoband, Models HB-NS and HB-NSXL (2009), cited by 2
- K994306: Reverso (2000), cited by 2
- K941851: Dual Lumen Catheter (DLC) Tray (1995), cited by 2
- K121599: Crit-Line Clip (Clic) (2012), cited by 2
- K071909: Prismacomfort, Model  Autocontrol 3XPT with Autoline XPT 4R (2007), cited by 2

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