# K053025: Jostra HLM Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Nov 10, 2005 after 14 days
- Product code: DWE (Tubing, Pump, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4390
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895753 (1989). 8 ancestors in all.
12 later devices descend from it; 3 cite it directly.
3 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833322: Tubing Connectors EC-2XXX Series, Gish Biomedical, Inc. (1983) Summary page 1.
- K771692: Tubing Sets, Cobe Laboratories, Inc. (1977) Summary page 1.
- K013578: Pump Tubing, Terumo Cardiovascular Systems Corp. (2002) Summary page 1.
- K041697: Terumo Circuit Connectors, Terumo Cardiovascular Systems Corporation (2004) Summary page 1.
- K881330: Cobe Heart/Lung Perfusion and Cardioplegia Pack, Cobe Laboratories, Inc. (1988) Summary page 1.
- K800178: Extracorp.'S Intersept Cus. Tubing PK., Extracorporeal Medical Specialities, Inc. (1980) Summary page 1.
- K023132: Jostra Mecc System, Jostra AG (2002) Summary page 1.

## Most influential descendants
- K080592: HLM Tubing Set with Bioline Coating (2008), 8 descendants of its own
- K090533: HLM Tubing Set with Softline Coating (2009), 3 descendants of its own
- K200109: OXY-1 System (2020), 2 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K092486: Vortex Medical Angiovac Cardiopulmonary Bypass Circuit (2009), 1 descendant of its own

## Recalls of this device
- May 22, 2017 · Class II · Z-0490-2018: 55 kits were distributed after their expiration date of September 2015.
- Jul 13, 2010 · Not classified · Z-2401-2010: The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.

## Indications for use
The Jostra HLM Tubing Set is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

Source page: https://510kreport.com/device/K053025
Methodology: https://510kreport.com/methodology