# K984338: Jostra HL-20 Twin Pump

- Pathway: 510(k) (Traditional)
- Applicant: Jostra Bentley
- Decided: Aug 19, 1999 after 259 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943803 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943803: Jostra HL-20 Integrated Perfusion System, Janus Biomedical, Inc. (1996) Summary page 1.

## Indications for use
The Jostra HL-20 Twin Pump is intended for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less. It is only intended for use with the Jostra HL-20 Heart Lung Machine.

Source page: https://510kreport.com/device/K984338
Methodology: https://510kreport.com/methodology