510(k) · Cleared
ClearedAlthin Medical AB Altracart II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Althin Medical AB · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Apr 15, 1999 as substantially equivalent to K873155 (Gambro, Inc., 1987) and 1 other predicate after a 101-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Apr 15, 1999
- Review
- 101 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K873155 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK873155 Gambro Bicart SystemGambro, Inc. · 1987
- This deviceK990010 Althin Medical AB Altracart IIAlthin Medical AB · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873155 | Gambro Bicart System | Gambro, Inc. | 1987 | — |
| 0 (this device) | K990010 | Althin Medical AB Altracart II | Althin Medical AB | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 KPO? 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 KPO device
- #1 K233159 pureFLOW 402, pureFLOW 400, pureFLOW 406…score 14.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K873155 | Gambro Bicart SystemSummary page 3…in design and construction to the currently marketed Gambro BiCart Columns which has been approved for marketing / sale in the United States under a 510K Notifications (K873155 and K940601). Both the predicate and the proposed devices, incorporate an identical compound, sodium bicarbonate and other dialys… | 1987 |
| * | K940601 | Gambro Bicart 720GSummary page 3…nd construction to the currently marketed Gambro BiCart Columns which has been approved for marketing / sale in the United States under a 510K Notifications (K873155 and K940601). Both the predicate and the proposed devices, incorporate an identical compound, sodium bicarbonate and other dialysis fluid con… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K873155.
How does its category compare?
All KPO devicesKPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPO
112in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPO
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPO
95in 2025
MAUDE reports naming product code KPO, 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 | 2 | — | 5 | 5 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 1 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 107 |
| 2011 | 1 | — | 2 | 223 |
| 2012 | 2 | — | 10 | 70 |
| 2013 | 1 | — | 0 | 3,897 |
| 2014 | 2 | — | 0 | 15,916 |
| 2015 | 1 | — | 3 | 8,340 |
| 2016 | 1 | — | 1 | 240 |
| 2017 | 3 | 192 | 1 | 80 |
| 2018 | 2 | — | 11 | 97 |
| 2019 | 0 | — | 1 | 79 |
| 2020 | 5 | 270 | 31 | 244 |
| 2021 | 1 | — | 0 | 63 |
| 2022 | 2 | — | 2 | 25 |
| 2023 | 3 | 263 | 0 | 59 |
| 2024 | 3 | 112 | 1 | 259 |
| 2025 | 2 | — | 6 | 95 |
| 2026 | 2 | — | 9 | — |
What is it indicated for?
The Althin Medical AB Altracart II is indicated for the preparation of sodium bicarbonate containing hemodialysis solutions for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine / monitor and acid concentrate solutions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990010 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990010: Althin Medical AB Altracart II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990010
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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