# K061832: Jostra HLM Tubing Sets with Safeline Coating

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Aug 11, 2006 after 43 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- 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 K932252 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053025: Jostra HLM Tubing Set, Maquet Cardiopulmonary, AG (2005) Summary page 1.
- K061072: Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32, Maquet Cardiopulmonary, AG (2006) Summary page 1.

## Indications for use
The Jostra HLM Tubing Set with Safeline Coating is indicated for use in surgical procedures requiring extracorporeal support for up to six hours The Safeline coating is used to reduce the surface tension on blood contact surfaces.

Source page: https://510kreport.com/device/K061832
Methodology: https://510kreport.com/methodology