510(k) · Cleared
Recalled · Class II · 2024Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Outset Medical, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on May 3, 2024 as substantially equivalent to K223248 (Outset Medical, Inc., 2023) after a 235-day review. Its family tree reaches back 13 generations to 1994. It has been recalled once.
- Decided
- May 3, 2024
- Review
- 235 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 13 generations to K921456 (1994). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 9 generations between
- 3 generations backK200741 Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · Recalled
- 2 generations backK211370 Tablo Hemodialysis SystemOutset Medical, Inc. · 2022 · Recalled
- 1 generation backK223248 Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023
- This deviceK232776 Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 12 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 11 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 10 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 9 generations backK111639 Fresenius 2008T Hemodialysis MachineFresenius Medical Care · 2011 · Recalled
- 8 generations backK113427 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America · 2011 · Recalled
- 7 generations backK120505 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 2012 · Recalled
- 6 generations backK140866 Tablo ConsoleHome Dialysis Plus · 2014
- 5 generations backK150880 Tablo Console with Wireless CapabilityOutset Medical · 2015
- 4 generations backK160881 Tablo ConsoleOutset Medical, Inc. · 2016
- 3 generations backK200741 Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · Recalled
- 2 generations backK211370 Tablo Hemodialysis SystemOutset Medical, Inc. · 2022 · Recalled
- 1 generation backK223248 Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023
- This deviceK232776 Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −12 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −11 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −10 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −9 | K111639 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care | 2011 | 1 |
| −8 | K113427 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2011 | 4 |
| −7 | K120505 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America, Design Cente | 2012 | 4 |
| −6 | K140866 | Tablo Console | Home Dialysis Plus | 2014 | — |
| −5 | K150880 | Tablo Console with Wireless Capability | Outset Medical | 2015 | — |
| −4 | K160881 | Tablo Console | Outset Medical, Inc. | 2016 | — |
| −3 | K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020 | 1 |
| −2 | K211370 | Tablo Hemodialysis System | Outset Medical, Inc. | 2022 | 1 |
| −1 | K223248 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023 | — |
| 0 (this device) | K232776 | Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer | Outset Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 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 KDI? 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 KDI device
- #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 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 |
|---|---|---|---|
| * | K223248 | Tablo® Hemodialysis SystemSummary page 6…al, Inc. Page 2 of 11 III. PREDICATE DEVICE The legally marketed predicate device to which substantial equivalence is claimed: Tablo Hemodialysis System, K223248 IV. MODIFICATION TO THE EXISTING DEVICE Modifications described in this Traditional 510(k) do not add, delete, or modify the de… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2024 | Class II | Z-2150-2024 | Device Design | A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 15 ancestors have a recall of any class.
- 2 other devices also cite its predicate K223248.
How does its category compare?
All KDI devicesKDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · KDI
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 2025
MAUDE reports naming product code KDI, 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 | 11 | 91 | 4 | 916 |
| 2008 | 6 | 148 | 0 | 1,042 |
| 2009 | 4 | 236 | 3 | 522 |
| 2010 | 9 | 186 | 1 | 823 |
| 2011 | 5 | 85 | 4 | 2,270 |
| 2012 | 6 | 153 | 1 | 1,765 |
| 2013 | 11 | 247 | 2 | 2,360 |
| 2014 | 8 | 164 | 3 | 6,154 |
| 2015 | 5 | 69 | 5 | 4,182 |
| 2016 | 5 | 230 | 4 | 766 |
| 2017 | 8 | 188 | 1 | 963 |
| 2018 | 2 | — | 1 | 1,716 |
| 2019 | 4 | 263 | 6 | 1,587 |
| 2020 | 9 | 266 | 0 | 1,633 |
| 2021 | 2 | — | 2 | 1,944 |
| 2022 | 7 | 259 | 17 | 2,180 |
| 2023 | 7 | 157 | 8 (8) | 2,692 |
| 2024 | 7 | 235 | 4 (2) | 2,441 |
| 2025 | 9 | 199 | 2 | 2,786 |
| 2026 | 6 | 154 | 2 | — |
What is it indicated for?
The Tablo® Hemodialysis System and TabloCart™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician’s prescription and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232776 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232776: Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232776
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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