# K023132: Jostra Mecc System

- Pathway: 510(k) (Traditional)
- Applicant: Jostra AG
- Decided: Dec 17, 2002 after 88 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 3 cite it directly.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bentley Duraflo Treated Extracorporeal Circuit: named in the summary without a submission number

## Most influential descendants
- K053025: Jostra HLM Tubing Set (2005), 12 descendants of its own
- K080592: HLM Tubing Set with Bioline Coating (2008), 8 descendants of its own
- K090006: Lifebridge B2T, Model 7001 (2009), 5 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

## Indications for use
The Jostra Mecc System is indicated for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.

Source page: https://510kreport.com/device/K023132
Methodology: https://510kreport.com/methodology