510(k) · Cleared
Cleared2008 Hemodialysis Sorbent System
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 Aug 13, 2010 as substantially equivalent to K070739 (Renal Solutions, Inc., 2007) and 1 other predicate after a 289-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Aug 13, 2010
- Review
- 289 days
- Class
- Class II
- Product code
- FKT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921456 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 2 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 1 generation backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- This deviceK093362 2008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK123835 2008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K1238352008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −2 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −1 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| 0 (this device) | K093362 | 2008 Hemodialysis Sorbent System | Renal Solutions, Inc. | 2010 | — |
| +1 | K123835 | 2008 Hemodialysis Sorbent System | Renal Solutions, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 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? (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 |
|---|---|---|---|
| * | K070739 | Allient Sorbent Hemodialysis System, Model# 1500Summary page 3…pproved for use; it is substantially equivalent to the Fresenius 2008T hemodialysis machine (K080964) and the Renal Solutions Allient® Sorbent Hemodialysis System (K070739). 2008 SorbentH-emodialysis System 510(k) Premarket Notification… | 2007 |
| * | K080964 | Fresenius Model 2008T Hemodialysis MachineSummary page 3…erates in a similar manner to standard hemodialysis systems currently approved for use; it is substantially equivalent to the Fresenius 2008T hemodialysis machine (K080964) and the Renal Solutions Allient® Sorbent Hemodialysis System (K070739). 2008 SorbentH-emodial… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123835 | 2008 Hemodialysis Sorbent System | 2013 | 0 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K123835 (Renal Solutions, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070739.
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. 2010, 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 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093362 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093362: 2008 Hemodialysis Sorbent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093362
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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