510(k) · Cleared
Recalled · Class I · 2024Tablo® 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 Dec 5, 2023 as substantially equivalent to K223248 (Outset Medical, Inc., 2023) after a 67-day review. Its family tree reaches back 13 generations to 1994. 1 of the 17 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Dec 5, 2023
- Review
- 67 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 3 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 13 generations to K921456 (1994). 15 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- 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 deviceK233335 Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253412 Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc. · 2026
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 deviceK233335 Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc. · 2026 · cites it directly0descendants
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) | K233335 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K223248 | 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, K223248 IV. INDICATION FOR USE The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, w… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2024 | Class II | Z-0019-2025 | Nonconforming Material/Component | Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss… |
| 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… |
| Mar 6, 2024 | Class I | Z-1485-2024 | Device Design | Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 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.
- Of its descendants, K253412 (Outset Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 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. 2023, 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. 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 as stated in the FDA summary.
https://510kreport.com/device/K233335 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233335: Tablo® Hemodialysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233335
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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