# K083158: Exalis, Software Version 1.15

- Pathway: 510(k) (Traditional)
- Applicant: Gambro, Inc.
- Decided: Jun 5, 2009 after 224 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- 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 K970989 (1997). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970989: Cyberren, Cybernius Medical, Ltd. (1997) Summary page 1.

## Most influential descendants
- K093379: TCX-I-DV Remote Care Management System (2010), 4 descendants of its own
- K131739: Nxstage Connected Health System (2013), 1 descendant of its own
- K101078: BL Healthcare Remote Care Management System (2010), 1 descendant of its own
- K181991: NxStage Connected Health System (2018), 0 descendants of its own
- K113493: TCX-I Remote Care Management System (2011), 0 descendants of its own

## Indications for use
Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data. Exalis is an accessory intended to be used with Gambro Phoenix Haemodialysis system (starting from software version 3.35) in a Chronic Dialysis Facility and at Limited Care Centers.

Source page: https://510kreport.com/device/K083158
Methodology: https://510kreport.com/methodology