# 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

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Sep 18, 2020 after 136 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953823 (1996). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172238: CAREline Airless Hemodialysis Blood Tubing Sets, Fresenius Medical Care Renal Therapies Group, LLC (2017) Summary page 4.
- K152953: Crit-Line Clip (Clic) Blood Chamber, Fresenius Medical Care North America (2015) Summary page 4.

## Most influential descendants
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own
- K213992: CombiSet Hemodialysis Blood Tubing Set (2023), 1 descendant of its own
- K251851: DIASAFEplusUS (F00013010) (2025), 0 descendants of its own
- K251442: TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (2025), 0 descendants of its own

## Indications for use
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician. 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 equipped with Crit-Line hardware. The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor’s sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation

Source page: https://510kreport.com/device/K201207
Methodology: https://510kreport.com/methodology