# K213992: CombiSet Hemodialysis Blood Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: May 31, 2023 after 526 days
- Product code: FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953823 (1996). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Fresenius Medical Care Renal Therapies Group, LLC (2020) Summary page 4.

## Most influential descendants
- K251442: TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (2025), 0 descendants of its own

## Recalls of this device
- Jul 29, 2026 · Class II · Z-3225-2026: Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

## Indications for use
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines.

Source page: https://510kreport.com/device/K213992
Methodology: https://510kreport.com/methodology