510(k) · Cleared
ClearedHemoCare Hemodialysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka Research and Development · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jul 12, 2024 as substantially equivalent to K010131 (Aksys, Ltd., 2002) and 3 other predicates after a 249-day review. Its family tree reaches back 12 generations to 1994.
- Decided
- Jul 12, 2024
- Review
- 249 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K921456 (1994). 44 ancestors in all, the oldest K770691 (1977). No later device cites it as a predicate yet.
- Root · 12 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 8 generations between
- 3 generations backK160881 Tablo ConsoleOutset Medical, Inc. · 2016
- 2 generations backK200741 Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · Recalled
- 1 generation backK211370 Tablo Hemodialysis SystemOutset Medical, Inc. · 2022 · Recalled
- This deviceK233557 HemoCare Hemodialysis SystemDeka Research and Development · 2024
Show all 12 generations
- Root · 12 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 11 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 10 generations backK080964 Fresenius Model 2008T Hemodialysis MachineFresenius Medical Care North America · 2009 · Recalled
- 9 generations backK093902 Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America · 2010 · Recalled
- 8 generations backK111639 Fresenius 2008T Hemodialysis MachineFresenius Medical Care · 2011 · Recalled
- 7 generations backK113427 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America · 2011 · Recalled
- 6 generations backK120505 Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 2012 · Recalled
- 5 generations backK140866 Tablo ConsoleHome Dialysis Plus · 2014
- 4 generations backK150880 Tablo Console with Wireless CapabilityOutset Medical · 2015
- 3 generations backK160881 Tablo ConsoleOutset Medical, Inc. · 2016
- 2 generations backK200741 Tablo Hemodialysis SystemOutset Medical, Inc. · 2020 · Recalled
- 1 generation backK211370 Tablo Hemodialysis SystemOutset Medical, Inc. · 2022 · Recalled
- This deviceK233557 HemoCare Hemodialysis SystemDeka Research and Development · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −11 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −10 | K080964 | Fresenius Model 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2009 | 4 |
| −9 | K093902 | Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 | Fresenius Medical Care North America | 2010 | 2 |
| −8 | K111639 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care | 2011 | 1 |
| −7 | K113427 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America | 2011 | 4 |
| −6 | K120505 | Fresenius 2008T Hemodialysis Machine | Fresenius Medical Care North America, Design Cente | 2012 | 4 |
| −5 | K140866 | Tablo Console | Home Dialysis Plus | 2014 | — |
| −4 | K150880 | Tablo Console with Wireless Capability | Outset Medical | 2015 | — |
| −3 | K160881 | Tablo Console | Outset Medical, Inc. | 2016 | — |
| −2 | K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020 | 1 |
| −1 | K211370 | Tablo Hemodialysis System | Outset Medical, Inc. | 2022 | 1 |
| 0 (this device) | K233557 | HemoCare Hemodialysis System | Deka Research and Development | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2022 | 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 KDI? 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? (4)
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 |
|---|---|---|---|
| * | K010131 | PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Summary page 6…Page 2 of 9 DEKA Research & Development Corp. 3 Predicate Device Predicate Device comparisons were made to the following four devices: • Aksys PHD (K010131, cleared on March 26, 2002) is indicated for the same therapy, the same user population and in the same use environments.… | 2002 |
| * | K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution FilterSummary page 6…s delivery, blood flow control, ultrafiltration, reusable blood treatment set, and automatic post-treatment device disinfection. • Nephros HDF Assist Module (K210575, cleared May 13, 2022) provides a predicate device that performs online generation of substitution fluid from commercially… | 2022 |
| * | K141752 | Nxstage System OneSummary page 6…device that performs online generation of substitution fluid from commercially available (510(k) cleared) chemical concentrates. • NxStage System One (K141752, cleared 12/19/2014) provides a predicate device that has the same home, nocturnal hemodialysis indication. • Outset… | 2014 |
| * | K211370 | Tablo Hemodialysis SystemSummary page 6…• NxStage System One (K141752, cleared 12/19/2014) provides a predicate device that has the same home, nocturnal hemodialysis indication. • Outset Tablo (K211370, cleared July 29, 2022) provides a predicate device since it features integrated water purification, and two-way wireless… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 15 of the 44 ancestors have a recall of any class.
- 4 other devices also cite its predicate K010131.
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. 2024, 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 HemoCare® Hemodialysis System is indicated for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare Hemodialysis System is indicated for use in chronic dialysis facilities, self-care dialysis facilities, and the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed with the assistance or observation of an individual who has been trained and is considered competent in the use of the device. The HemoCare Hemodialysis System is not indicated for solo hemodialysis in the home setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233557: HemoCare 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/K233557
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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