510(k) · Cleared
ClearedTablo Hemodialysis System (PN-0008000, PN-0006000U)
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 Jan 26, 2026 as substantially equivalent to K233335 (Outset Medical, Inc., 2023) after a 118-day review. Its family tree reaches back 14 generations to 1994. 1 of the 17 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 26, 2026
- Review
- 118 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K921456 (1994). 16 ancestors in all. No later device cites it as a predicate yet. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 10 generations between
- 3 generations backK211370 Tablo Hemodialysis SystemOutset Medical, Inc. · 2022 · Recalled
- 2 generations backK223248 Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023
- 1 generation backK233335 Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023 · Recalled (Class I)
- This deviceK253412 Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 13 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 12 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 11 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 10 generations backK111639 Fresenius 2008T Hemodialysis MachineFresenius Medical Care · 2011 · Recalled
- 9 generations backK113427 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America · 2011 · Recalled
- 8 generations backK120505 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 2012 · Recalled
- 7 generations backK140866 Tablo ConsoleHome Dialysis Plus · 2014
- 6 generations backK150880 Tablo Console with Wireless CapabilityOutset Medical · 2015
- 5 generations backK160881 Tablo ConsoleOutset Medical, Inc. · 2016
- 4 generations backK200741 Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · Recalled
- 3 generations backK211370 Tablo Hemodialysis SystemOutset Medical, Inc. · 2022 · Recalled
- 2 generations backK223248 Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023
- 1 generation backK233335 Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023 · Recalled (Class I)
- This deviceK253412 Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc. · 2026
Class I recalls in this family
- K233335 Tablo® Hemodialysis Systemdirect predicate · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −13 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −12 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −11 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −10 | K111639 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care | 2011 | 1 |
| −9 | K113427 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2011 | 4 |
| −8 | K120505 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America, Design Cente | 2012 | 4 |
| −7 | K140866 | Tablo Console | Home Dialysis Plus | 2014 | — |
| −6 | K150880 | Tablo Console with Wireless Capability | Outset Medical | 2015 | — |
| −5 | K160881 | Tablo Console | Outset Medical, Inc. | 2016 | — |
| −4 | K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020 | 1 |
| −3 | K211370 | Tablo Hemodialysis System | Outset Medical, Inc. | 2022 | 1 |
| −2 | K223248 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023 | — |
| −1 | K233335 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023 | Class I |
| 0 (this device) | K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | 2026 | — |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K233335 | Tablo® Hemodialysis SystemSummary page 5…KDI; FIP Regulatory Class: II III. PREDICATE DEVICE The predicate device to which substantial equivalence is claimed is: Tablo Hemodialysis System, K233335 IV. INDICATION FOR USE The Tablo® Hemodialysis System and TabloCart™ are indicated for use in patients with acute and/or chronic… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K233335Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 10 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
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. 2026, 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™ are indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility, and/or in the home. Treatments must be administered under a physician’s prescription and observed by a trained individual who is considered competent in the use of the device. 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/K253412 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253412: Tablo Hemodialysis System (PN-0008000, PN-0006000U).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253412
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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