510(k) · Cleared
ClearedTablo Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Dialysis Plus · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Sep 11, 2014 as substantially equivalent to K120823 (Fresenius Medical Care North America, Design Cente, 2012) after a 162-day review. Its family tree reaches back 3 generations to 2001. 7 later devices descend from it.
- Decided
- Sep 11, 2014
- Review
- 162 days
- Class
- Class II
- Product code
- FJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010264 (2001). 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010264 Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors…Nipro Medical Corp. · 2001
- 2 generations backK082719 Nikkline Blood Tubing Lines with Transducer Protectors, Models…Nikkiso CO., LTD. · 2009
- 1 generation backK120823 BVM Hemodialysis Blood Tubing Set with Attached Priming Set and…Fresenius Medical Care North America, Design Cente · 2012
- This deviceK140841 Tablo CartridgeHome Dialysis Plus · 2014
- Descendant · cites it directly · 3 of its ownK193670 SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK210661 SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK190793 Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK210782 Tablo CartridgeOutset Medical, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK242269 SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656)…Quanta Dialysis Technologies, Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd. · 2020 · cites it directly3descendants
- K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd. · 2021 · 2 generations on2descendants
- K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc. · 2019 · cites it directly2descendants
- K210782Tablo CartridgeOutset Medical, Inc. · 2021 · 2 generations on1descendant
- K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010264 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming… | Nipro Medical Corp. | 2001 | — |
| −2 | K082719 | Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P… | Nikkiso CO., LTD. | 2009 | — |
| −1 | K120823 | BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer… | Fresenius Medical Care North America, Design Cente | 2012 | — |
| 0 (this device) | K140841 | Tablo Cartridge | Home Dialysis Plus | 2014 | — |
| +1 | K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set | Quanta Dialysis Technologies, Ltd. | 2020 | — |
| +2 | K210661 | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset | Quanta Dialysis Technologies, Ltd. | 2021 | — |
| +1 | K190793 | Tablo Hemodialysis System, Tablo Cartridge | Outset Medical, Inc. | 2019 | 2 |
| +2 | K210782 | Tablo Cartridge | Outset Medical, Inc. | 2021 | — |
| +3 | K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube… | Quanta Dialysis Technologies, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K120823 | BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer ProtectorsSummary page 5…RegurgitationValve) ClassificationPanel: Gastroenterology/Urology 5.3 PredicateDeviceInformation FreseniusBloodTubingSet(K120823) 5.4 DeviceDescription TheTablo™CartridgecomprisesasingleͲuse,sterileBloodTubingSetattachedtoanOrganizer. T… | 2012 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K193670 (Quanta Dialysis Technologies, Ltd., 2020) has gone furthest, with 3 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. 2014, 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 extracorporeal 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/K140841 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140841: Tablo Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140841
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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