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 Feb 15, 2013 as substantially equivalent to K093362 (Renal Solutions, Inc., 2010) after a 64-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Feb 15, 2013
- Review
- 64 days
- Class
- Class II
- Product code
- FKT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921456 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 3 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 2 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 1 generation backK093362 2008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2010
- This deviceK123835 2008 Hemodialysis Sorbent SystemRenal Solutions, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −3 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −2 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −1 | K093362 | 2008 Hemodialysis Sorbent System | Renal Solutions, Inc. | 2010 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K093362 | 2008 Hemodialysis Sorbent SystemSummary page 1…rbent Regenerated Regulation Number 876.5600 Proprietary Name 2008 Sorbent System Unmodified Device 2008 Sorbent System (K093362) Reason for Submission Modification to existing device Device Description The 2008 Sorbent System is inte… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 3 of the 5 ancestors have a recall of any class.
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. 2013, 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/K123835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123835: 2008 Hemodialysis Sorbent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123835
Report an extraction error
Are you the manufacturer?
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