510(k) · Cleared
Recalled · Class II · 2023Tablo Hemodialysis System
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 Jul 29, 2022 as substantially equivalent to K200741 (Outset Medical, Inc., 2020) after a 451-day review. Its family tree reaches back 11 generations to 1994. 1 of the 20 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled once.
- Decided
- Jul 29, 2022
- Review
- 451 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K921456 (1994). 13 ancestors in all. 6 later devices descend from it, 2 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 7 generations between
- 3 generations backK150880 Tablo Console with Wireless CapabilityOutset Medical · 2015
- 2 generations backK160881 Tablo ConsoleOutset Medical, Inc. · 2016
- 1 generation backK200741 Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · Recalled
- This deviceK211370 Tablo Hemodialysis SystemOutset Medical, Inc. · 2022
- Descendant · cites it directly · 4 of its ownK223248 Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK233335 Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK253412 Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK233798 Moda-flx Hemodialysis System and CartridgeDiality, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK233557 HemoCare Hemodialysis SystemDeka Research and Development · 2024
Show all 11 generations
- Root · 11 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 10 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 9 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 8 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 7 generations backK111639 Fresenius 2008T Hemodialysis MachineFresenius Medical Care · 2011 · Recalled
- 6 generations backK113427 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America · 2011 · Recalled
- 5 generations backK120505 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 2012 · Recalled
- 4 generations backK140866 Tablo ConsoleHome Dialysis Plus · 2014
- 3 generations backK150880 Tablo Console with Wireless CapabilityOutset Medical · 2015
- 2 generations backK160881 Tablo ConsoleOutset Medical, Inc. · 2016
- 1 generation backK200741 Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · Recalled
- This deviceK211370 Tablo Hemodialysis SystemOutset Medical, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233335 Tablo® Hemodialysis System2 generations on · 2023
Most influential descendants
Showing 5 of 6 · See all- K223248Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023 · cites it directly4descendants
- K233335Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023 · 2 generations on1descendant
- K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc. · 2026 · 3 generations on0descendants
- K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc. · 2024 · 2 generations on0descendants
- K233557HemoCare Hemodialysis SystemDeka Research and Development · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −10 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −9 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −8 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −7 | K111639 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care | 2011 | 1 |
| −6 | K113427 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2011 | 4 |
| −5 | K120505 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America, Design Cente | 2012 | 4 |
| −4 | K140866 | Tablo Console | Home Dialysis Plus | 2014 | — |
| −3 | K150880 | Tablo Console with Wireless Capability | Outset Medical | 2015 | — |
| −2 | K160881 | Tablo Console | Outset Medical, Inc. | 2016 | — |
| −1 | K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020 | 1 |
| 0 (this device) | K211370 | Tablo Hemodialysis System | Outset Medical, Inc. | 2022 | — |
| +1 | K223248 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023 | — |
| +2 | K233335 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023 | Class I |
| +3 | K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | 2026 | — |
| +2 | K233798 | Moda-flx Hemodialysis System and Cartridge | Diality, Inc. | 2024 | — |
| +1 | K233557 | HemoCare Hemodialysis System | Deka Research and Development | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 1 |
| 2024 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K200741 | Tablo Hemodialysis SystemSummary page 4…KDI; FIP Regulatory Class: II III. PREDICATE DEVICE The predicate device to which substantial equivalence is claimed is: Tablo Hemodialysis System, K200741 Additionally, the following device is used as a reference device to support the device differences: Tablo Hemodialysis System, K… | 2020 |
| † | K190793 | Tablo Hemodialysis System, Tablo Cartridge | 2019 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2023 | Class II | Z-1351-2023 | Process control | An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process. |
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 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 13 ancestors have a recall of any class.
- Of its descendants, K223248 (Outset Medical, Inc., 2023) has gone furthest, with 4 descendants of its own.
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. 2022, 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 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.
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/K211370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211370: Tablo Hemodialysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211370
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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