510(k) · Cleared
ClearedSorb+Hisorb+Cartridge
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 Sep 17, 2003 as substantially equivalent to K811170 (Organon Teknika Corp., 1981) and 1 other predicate after a 163-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Sep 17, 2003
- Review
- 163 days
- Class
- Class II
- Product code
- FKT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K811170 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK811170 D-3160 Sorbent CartridgeOrganon Teknika Corp. · 1981
- This deviceK031099 Sorb+Hisorb+CartridgeRenal Solutions, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811170 | D-3160 Sorbent Cartridge | Organon Teknika Corp. | 1981 | — |
| 0 (this device) | K031099 | Sorb+Hisorb+Cartridge | Renal Solutions, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 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 |
|---|---|---|---|
| * | K811170 | D-3160 Sorbent CartridgeSummary page 1…RB+ Common System, Dialysate Delivery, Sorbent Regenerated, Accessory Name Classification Class I1 per 2 1CFR876.5600 code FKT Predicate K8 1 1170- SORB 3 160- manufactured by Sorb Technology Device K8 12869-HISORB 3260- manufactured by Sorb Technology Informati… | 1981 |
| * | K812869 | D-3260 Sorbent CartridgeSummary page 1…ccessory Name Classification Class I1 per 2 1CFR876.5600 code FKT Predicate K8 1 1170- SORB 3 160- manufactured by Sorb Technology Device K8 12869-HISORB 3260- manufactured by Sorb Technology Information 1 Summary o f Safety a… | 1981 |
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?
- None of the 2 ancestors has a recall.
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.
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 SORB+ and HISORB+ Cartridges are to be used only with Renal Solutions' REDY Sorbant Dialysis systems for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031099: Sorb+Hisorb+Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031099
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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