510(k) · Cleared
ClearedBicart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Jan 8, 2002 as substantially equivalent to K873155 (Gambro, Inc., 1987) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1987. 3 of the 24 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.
- Decided
- Jan 8, 2002
- Review
- 60 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. 21 later devices descend from it, 5 citing it directly. 3 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK873155 Gambro Bicart SystemGambro, Inc. · 1987
- This deviceK013724 BicartGambro Renal Products · 2002
- Descendant · cites it directly · 15 of its ownK101715 Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · Recalled
- Descendant · 2 generations on · 14 of its ownK120017 Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- Descendant · 3 generations on · 13 of its ownK121341 Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- Descendant · 4 generations on · 11 of its ownK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
- Descendant · 4 generations on · 10 of its ownK131908 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K101715Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · cites it directly15descendants
- K120017Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · 2 generations on14descendants
- K121341Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · 3 generations on13descendants
- K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013 · 4 generations on11descendants
- K1319082008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC · 2013 · 4 generations on10descendants
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) | K013724 | Bicart | Gambro Renal Products | 2002 | — |
| +1 | K101715 | Fresenius 2008T Hemodialysis Machine Model 190573 | Fresenius Medical Care North America, Design Cente | 2010 | 1 |
| +2 | K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 3 |
| +3 | K121341 | Fresenius 2008T Hemodialysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 5 |
| +4 | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | — |
| +4 | K131908 | 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic) | Fresenius Medical Care Renal Therapies Group, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2018 | 1 | 1 |
| 2022 | 2 | 1 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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.
3 devices in this family have a Class I recall. 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 2…on Name: Dialysate Concentrate for Hemodialysis (Liquid or Powder) per 21 CFR 876.5820. The Product/Classification Code is KPO. Predicate Devices: Gambro BiCart® System K873155 cleared 10/26/1987 Gambro, Inc. Manufactured by Gambro Lundia AB Gambro BiCart® 720g K940601 cleared 03/22/1994 C.G.H Medical… | 1987 |
| * | K940601 | Gambro Bicart 720GSummary page 2…uct/Classification Code is KPO. Predicate Devices: Gambro BiCart® System K873155 cleared 10/26/1987 Gambro, Inc. Manufactured by Gambro Lundia AB Gambro BiCart® 720g K940601 cleared 03/22/1994 C.G.H Medical, Inc. Manufactured by Gambro Lundia AB Device Description: Gambro BiCart® Sodium Bicarbonate… | 1994 |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 18 Class I recalls
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 7 generations on · ◆ in the 2018 descendants bar of FIG. 18 Class I recalls
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 8 generations on · ◆ in the 2022 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
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?
Gambro BiCart® is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
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/K013724 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013724: Bicart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013724
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026