# K943803: Jostra HL-20 Integrated Perfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Janus Biomedical, Inc.
- Decided: Jan 30, 1996 after 544 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- K984338: Jostra HL-20 Twin Pump (1999), 0 descendants of its own

## Recalls of this device
- Jun 20, 2011 · Not classified · Z-3057-2011: HL 20 Consoles for 4-pump and 5-pump configuration can malfunction if an excessive amount of liquid is used causing circuit board malfunction.
- Jun 20, 2011 · Not classified · Z-3084-2011: Maquet HL 20 Twin Pump Modules may unintentionally increase speeds for a 1.5-2 second period of time before returning to its original speed.
- Sep 28, 2010 · Not classified · Z-1394-2011: A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.
- Oct 3, 2006 · Not classified · Z-0159-2007: The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other partic
- Sep 1, 2006 · Not classified · Z-0158-2007: The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.

Source page: https://510kreport.com/device/K943803
Methodology: https://510kreport.com/methodology