# K090533: HLM Tubing Set with Softline Coating

- Pathway: 510(k) (Special)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Dec 18, 2009 after 294 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: 7 generations back to K922933 (1992). 27 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080592: HLM Tubing Set with Bioline Coating, Maquet Cardiopulmonary, AG (2008) Summary page 1.
- K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000, Maquet Cardiopulmonary, AG (2009) Summary page 1.

## Most influential descendants
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own
- K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own

## Indications for use
The HLM Tubing Sets with Softline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.

Source page: https://510kreport.com/device/K090533
Methodology: https://510kreport.com/methodology