510(k) · Cleared
ClearedExalis, Software Version 1.15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jun 5, 2009 as substantially equivalent to K970989 (Cybernius Medical, Ltd., 1997) after a 224-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Jun 5, 2009
- Review
- 224 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970989 (1997). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970989 CyberrenCybernius Medical, Ltd. · 1997
- This deviceK083158 Exalis, Software Version 1.15Gambro, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK131739 Nxstage Connected Health SystemNxstage Medical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK101078 BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK181991 NxStage Connected Health SystemNxstage Medical, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK113493 TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010 · cites it directly4descendants
- K131739Nxstage Connected Health SystemNxstage Medical, Inc. · 2013 · 2 generations on1descendant
- K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010 · 2 generations on1descendant
- K181991NxStage Connected Health SystemNxstage Medical, Inc. · 2018 · 3 generations on0descendants
- K113493TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970989 | Cyberren | Cybernius Medical, Ltd. | 1997 | — |
| 0 (this device) | K083158 | Exalis, Software Version 1.15 | Gambro, Inc. | 2009 | — |
| +1 | K093379 | TCX-I-DV Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +2 | K131739 | Nxstage Connected Health System | Nxstage Medical, Inc. | 2013 | — |
| +2 | K101078 | BL Healthcare Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +3 | K181991 | NxStage Connected Health System | Nxstage Medical, Inc. | 2018 | — |
| +3 | K113493 | TCX-I Remote Care Management System | Bl Healthcare, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KDI device
- #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970989 | CyberrenSummary page 1…is Facility and at Limited Care Centers. CyberRenw Clinical Data Management System 5 10(k) Number: K970989 Identification of the Classification Name: Hemodialysis System and accessories Legally Marketed Device De… | 1997 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093379 | TCX-I-DV Remote Care Management System | 2010 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K093379 (Bl Healthcare, Inc., 2010) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KDI devicesKDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KDI
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 2025
MAUDE reports naming product code KDI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 91 | 4 | 916 |
| 2008 | 6 | 148 | 0 | 1,042 |
| 2009 | 4 | 236 | 3 | 522 |
| 2010 | 9 | 186 | 1 | 823 |
| 2011 | 5 | 85 | 4 | 2,270 |
| 2012 | 6 | 153 | 1 | 1,765 |
| 2013 | 11 | 247 | 2 | 2,360 |
| 2014 | 8 | 164 | 3 | 6,154 |
| 2015 | 5 | 69 | 5 | 4,182 |
| 2016 | 5 | 230 | 4 | 766 |
| 2017 | 8 | 188 | 1 | 963 |
| 2018 | 2 | — | 1 | 1,716 |
| 2019 | 4 | 263 | 6 | 1,587 |
| 2020 | 9 | 266 | 0 | 1,633 |
| 2021 | 2 | — | 2 | 1,944 |
| 2022 | 7 | 259 | 17 | 2,180 |
| 2023 | 7 | 157 | 8 (8) | 2,692 |
| 2024 | 7 | 235 | 4 (2) | 2,441 |
| 2025 | 9 | 199 | 2 | 2,786 |
| 2026 | 6 | 154 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083158: Exalis, Software Version 1.15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083158
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026