510(k) · Cleared
ClearedGambro Bicart 720G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.G.H. Medical, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Mar 22, 1994 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 24 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it.
- Decided
- Mar 22, 1994
- Review
- 40 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 3 citing it directly. 3 of the 24 devices in this family, counting this one, have a Class I recall.
- This deviceK940601 Gambro Bicart 720GC.G.H. Medical, Inc. · 1994
- Descendant · cites it directly · 21 of its ownK013724 BicartGambro Renal Products · 2002
- Descendant · 2 generations on · 15 of its ownK101715 Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · Recalled
- Descendant · 3 generations on · 14 of its ownK120017 Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- Descendant · 4 generations on · 13 of its ownK121341 Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · Recalled
- Descendant · 5 generations on · 11 of its ownK124035 2008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 23 · See all- K013724BicartGambro Renal Products · 2002 · cites it directly21descendants
- K101715Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 2010 · 2 generations on15descendants
- K120017Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · 3 generations on14descendants
- K121341Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America · 2012 · 4 generations on13descendants
- K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America · 2013 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940601 | Gambro Bicart 720G | C.G.H. Medical, Inc. | 1994 | — |
| +1 | K013724 | Bicart | Gambro Renal Products | 2002 | — |
| +2 | K101715 | Fresenius 2008T Hemodialysis Machine Model 190573 | Fresenius Medical Care North America, Design Cente | 2010 | 1 |
| +3 | K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 3 |
| +4 | K121341 | Fresenius 2008T Hemodialysis Machine with Bibag System | Fresenius Medical Care North America | 2012 | 5 |
| +5 | K124035 | 2008K@Home Hemodialysis Machine | Fresenius Medical Care North America | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (23)
See all 233 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 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 18 Class I recalls
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 8 generations on · ◆ in the 2018 descendants bar of FIG. 18 Class I recalls
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 9 generations on · ◆ in the 2022 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- Of its descendants, K013724 (Gambro Renal Products, 2002) has gone furthest, with 21 descendants of its own.
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 | — |
https://510kreport.com/device/K940601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940601: Gambro Bicart 720G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940601
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026