510(k) · Cleared
ClearedEdwards Aquarius System, Model GE-F098-00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences Services GmbH · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Nov 19, 2009 as substantially equivalent to K070320 (Edwards Lifesciences Services GmbH, 2007) after a 248-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Nov 19, 2009
- Review
- 248 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K910215 (1991). 18 ancestors in all, the oldest K873279 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK910215 Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 1991 · Recalled
- 5 generations backK954987 Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996 · Recalled
- 4 generations backK970446 Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · Recalled
- 3 generations backK993064 Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · Recalled
- 2 generations backK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · Recalled
- 1 generation backK070320 Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH · 2007 · Recalled
- This deviceK090682 Edwards Aquarius System, Model GE-F098-00Edwards Lifesciences Services GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910215 | Drake Willock System 1000 Dialysate Delivery Syst | Cd Medical, Inc. | 1991 | 5 |
| −5 | K954987 | Altratouch 1000 Hemodialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1996 | 1 |
| −4 | K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1997 | 5 |
| −3 | K993064 | Prisma CFM (Continuous Fluid Management System) | Gambro Renal Care Products | 1999 | 1 |
| −2 | K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corp | 2002 | 3 |
| −1 | K070320 | Edwards Aquarius Hemofiltration System, Model Abm 01 | Edwards Lifesciences Services GmbH | 2007 | 1 |
| 0 (this device) | K090682 | Edwards Aquarius System, Model GE-F098-00 | Edwards Lifesciences Services GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 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? (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 |
|---|---|---|---|
| * | K070320 | Edwards Aquarius Hemofiltration System, Model Abm 01Summary page 2…(78 KDI) as a Class II. Common Name: Hemofiltration System Predicate Device: Edwards Aquarius system cleared under premarket notification K070320 on June 7, 2007 Brief Description: The general description of the device has not changed from the predicat… | 2007 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 18 ancestors have a recall of any class.
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. 2009, 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 Edwards Aquarius System is indicated for continuous solute and/or fluid removal in
patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be
used in Therapeutic Plasma Exchange (TPE) therapies.
The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090682: Edwards Aquarius System, Model GE-F098-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090682
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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