510(k) · Cleared
ClearedSolcart B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B. Braun Medizintechnologie GmbH · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Jan 29, 2008 as substantially equivalent to K013724 (Gambro Renal Products, 2002) after a 123-day review. Its family tree reaches back 2 generations to 1987. 2 later devices descend from it.
- Decided
- Jan 29, 2008
- Review
- 123 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873155 (1987). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK873155 Gambro Bicart SystemGambro, Inc. · 1987
- 1 generation backK013724 BicartGambro Renal Products · 2002
- This deviceK072760 Solcart BB. Braun Medizintechnologie GmbH · 2008
- Descendant · cites it directly · 1 of its ownK102194 Solcart BB. Braun Avitum AG · 2011
- Descendant · cites it directly · 0 of its ownK202508 Hemo-Lyte C CartridgeDi-Chem, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873155 | Gambro Bicart System | Gambro, Inc. | 1987 | — |
| −1 | K013724 | Bicart | Gambro Renal Products | 2002 | — |
| 0 (this device) | K072760 | Solcart B | B. Braun Medizintechnologie GmbH | 2008 | — |
| +1 | K102194 | Solcart B | B. Braun Avitum AG | 2011 | — |
| +1 | K202508 | Hemo-Lyte C Cartridge | Di-Chem, Inc. | 2022 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K013724 | BicartSummary page 1…ialysis DEVICE CLASSIFICATION: Hemodialysis system and accessories Class H1,CFR Title 21 § 876.5820 PREDICATE DEVICE: Garnbro BiCari:® (K013724) DESCRIPTION: Solcart B consists of a powder concentrate used to prepare bicarbonate concentrate… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 14.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102194 (B. Braun Avitum AG, 2011) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K013724.
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. 2008, this device’s year, is highlighted.
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?
Solcart B is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072760 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072760: Solcart B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072760
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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