510(k) · Cleared
ClearedAllient Sorbent Hemodialysis System, Model# 1500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renal Solutions, Inc. · FKT System, Dialysate Delivery, Sorbent Regenerated
Cleared on May 25, 2007 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- May 25, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- FKT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK070739 Allient Sorbent Hemodialysis System, Model# 1500Renal Solutions, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK093964 Venofer PumpRenal Solutions, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK103564 Venofer PumpRenal Solutions, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK093362 2008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK123835 2008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK121497 Venofer PumpRenal Solutions, Inc. · 2012 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K093964Venofer PumpRenal Solutions, Inc. · 2010 · cites it directly2descendants
- K103564Venofer PumpRenal Solutions, Inc. · 2011 · 2 generations on1descendant
- K0933622008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2010 · cites it directly1descendant
- K1238352008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2013 · 2 generations on0descendants
- K121497Venofer PumpRenal Solutions, Inc. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070739 | Allient Sorbent Hemodialysis System, Model# 1500 | Renal Solutions, Inc. | 2007 | — |
| +1 | K093964 | Venofer Pump | Renal Solutions, Inc. | 2010 | — |
| +2 | K103564 | Venofer Pump | Renal Solutions, Inc. | 2011 | — |
| +1 | K093362 | 2008 Hemodialysis Sorbent System | Renal Solutions, Inc. | 2010 | — |
| +2 | K123835 | 2008 Hemodialysis Sorbent System | Renal Solutions, Inc. | 2013 | — |
| +3 | K121497 | Venofer Pump | Renal Solutions, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FKT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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?
- Of its descendants, K093964 (Renal Solutions, Inc., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FKT devicesFKT System, Dialysate Delivery, Sorbent Regenerated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FKT
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FKT
Too few FKT 510(k)s in any year since 2007 to give a median.
Recalls per year · FKT
No recall names FKT since 2007.
Adverse event reports per year · FKT
1in 2012
MAUDE reports naming product code FKT, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Allient Sorbent Hemodialysis System, including the SORB TM series and HISORB TM series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K070739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070739: Allient Sorbent Hemodialysis System, Model# 1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070739
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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