510(k) · Cleared
ClearedTablo Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Outset Medical, Inc. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Nov 26, 2021 as substantially equivalent to K190793 (Outset Medical, Inc., 2019) after a 255-day review. Its family tree reaches back 11 generations to 1994. 1 later device descends from it.
- Decided
- Nov 26, 2021
- Review
- 255 days
- Class
- Class II
- Product code
- FJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K921456 (1994). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK190793 Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc. · 2019 · Recalled
- This deviceK210782 Tablo CartridgeOutset Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK233798 Moda-flx Hemodialysis System and CartridgeDiality, Inc. · 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 backK190793 Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc. · 2019 · Recalled
- This deviceK210782 Tablo CartridgeOutset Medical, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc. · 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 | K190793 | Tablo Hemodialysis System, Tablo Cartridge | Outset Medical, Inc. | 2019 | 2 |
| 0 (this device) | K210782 | Tablo Cartridge | Outset Medical, Inc. | 2021 | — |
| +1 | K233798 | Moda-flx Hemodialysis System and Cartridge | Diality, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 FJK? 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 FJK device
- #1 K252423 NovaLine Tubing Set for Hemodialysis (BL 124)score 12.2 · 4 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 |
|---|---|---|---|
| * | K190793 | Tablo Hemodialysis System, Tablo CartridgeSummary page 4…essories Regulation Number: 21 CFR § 876.5820 Product Code: FJK Regulatory Class: II III. PREDICATE DEVICE Tablo Cartridge (K190793) The predicate device has not been subjected to a design related recall. No reference devices were used in this submission. IV.… | 2019 |
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 |
|---|---|---|---|
| K233798 | Moda-flx Hemodialysis System and Cartridge | 2024 | 0 |
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?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 17 ancestors have a recall of any class.
- Of its descendants, K233798 (Diality, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FJK devicesFJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FJK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FJK
255in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FJK
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FJK
1,487in 2025
MAUDE reports naming product code FJK, 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 | 4 | 116 | 2 | 135 |
| 2008 | 1 | — | 2 | 86 |
| 2009 | 1 | — | 0 | 76 |
| 2010 | 1 | — | 2 | 130 |
| 2011 | 0 | — | 0 | 243 |
| 2012 | 2 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 114 |
| 2014 | 1 | — | 0 | 116 |
| 2015 | 0 | — | 1 | 126 |
| 2016 | 1 | — | 0 | 139 |
| 2017 | 1 | — | 0 | 131 |
| 2018 | 1 | — | 0 | 119 |
| 2019 | 0 | — | 0 | 185 |
| 2020 | 0 | — | 1 | 190 |
| 2021 | 3 | 255 | 0 | 188 |
| 2022 | 0 | — | 0 | 362 |
| 2023 | 1 | — | 0 | 585 |
| 2024 | 1 | — | 0 | 417 |
| 2025 | 1 | — | 1 (1) | 1,487 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210782: Tablo Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210782
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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