510(k) · Cleared
Recalled · 2009Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys 1000, L3 with N100 Arm, 4B Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Dec 12, 2002 as substantially equivalent to K910215 (Cd Medical, Inc., 1991) and 5 other predicates after a 412-day review. Its family tree reaches back 3 generations to 1991. It has been recalled 2 times.
- Decided
- Dec 12, 2002
- Review
- 412 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 3 generations to K910215 (1991). 12 ancestors in all, the oldest K873279 (1987). No later device cites it as a predicate yet.
- Root · 3 generations backK910215 Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 1991 · Recalled
- 2 generations backK954987 Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996 · Recalled
- 1 generation backK964922 Drake Willock System 1000 Dialysate Delivery System Altratouch 1000…Althin Medical AB an Affiliate of Baxter Intl · 1997
- This deviceK013562 Aurora System 1000 Series Home Self-Care Single Patient Delivery…Baxter Healthcare Corp · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910215 | Drake Willock System 1000 Dialysate Delivery Syst | Cd Medical, Inc. | 1991 | 5 |
| −2 | K954987 | Altratouch 1000 Hemodialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1996 | 1 |
| −1 | K964922 | Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate… | Althin Medical AB an Affiliate of Baxter Intl | 1997 | — |
| 0 (this device) | K013562 | Aurora System 1000 Series Home Self-Care Single Patient Delivery System… | Baxter Healthcare Corp | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 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? (6)
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 |
|---|---|---|---|
| * | K910215 | Drake Willock System 1000 Dialysate Delivery Syst | 1991 |
| * | K954987 | Altratouch 1000 Hemodialysis Delivery System | 1996 |
| * | K955384 | Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen OptionSummary page 1…) numbers ti9 102 15 System 1000, Dialysis Delivery System, K9.54987 AltraTouch 1000 Machine, ti955384 SND option, K964922 AutoStart option and K970446 Hematocrit and Blood Volume… | 1997 |
| * | K964922 | Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery…Summary page 1…ti9 102 15 System 1000, Dialysis Delivery System, K9.54987 AltraTouch 1000 Machine, ti955384 SND option, K964922 AutoStart option and K970446 Hematocrit and Blood Volume… | 1997 |
| * | K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemSummary page 1…ery System, K9.54987 AltraTouch 1000 Machine, ti955384 SND option, K964922 AutoStart option and K970446 Hematocrit and Blood Volume Monitor option and ti992894 Meridian Hemodialysis… | 1997 |
| * | K992894 | Meridian Hemodialysis Machine, Model 5M5576Summary page 1…D option, K964922 AutoStart option and K970446 Hematocrit and Blood Volume Monitor option and ti992894 Meridian Hemodialysis Machine]. The AURORATMSystem 1000… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2009 | Not classified | Z-0179-2010 | Software design | When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's manual. |
| Nov 18, 2005 | Not classified | Z-0347-06 | Other | Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air emboli condition. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 5 of the 12 ancestors have a recall of any class.
- 3 other devices also cite its predicate K910215.
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.
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 AURORATMSystem 1OOO@ Series Single Patient Dialysis Delivery System is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Aurora System 1000 include a high blood flow rate capacity, automatic…
Read the full statement (119 words)
The AURORATMSystem 1OOO@ Series Single Patient Dialysis Delivery System is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Aurora System 1000 include a high blood flow rate capacity, automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Aurora System 1000 Instrument will operate in either the bicarbonate or acetate mode for concentrates.
The AURORATMSystem 1OOO@Series Single Patient Dialysis Delivery System is designed to operate in the chronic and acute dialysis environment. It is not for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013562: Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys 1000, L3 with N100 Arm, 4B Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013562
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026