510(k) · Cleared
Recalled · 2009Edwards Aquarius Hemofiltration System, Model Abm 01
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 Jun 7, 2007 as substantially equivalent to K021615 (Baxter Healthcare Corp, 2002) and 4 other predicates after a 125-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 7, 2007
- Review
- 125 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 5 generations to K910215 (1991). 17 ancestors in all, the oldest K873279 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK910215 Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 1991 · Recalled
- 4 generations backK954987 Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996 · Recalled
- 3 generations backK970446 Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · Recalled
- 2 generations backK993064 Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · Recalled
- 1 generation backK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · Recalled
- This deviceK070320 Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH · 2007
- Descendant · cites it directly · 0 of its ownK090682 Edwards Aquarius System, Model GE-F098-00Edwards Lifesciences Services GmbH · 2009
Most influential descendants
Showing 1 of 1 · See all- K090682Edwards Aquarius System, Model GE-F098-00Edwards Lifesciences Services GmbH · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910215 | Drake Willock System 1000 Dialysate Delivery Syst | Cd Medical, Inc. | 1991 | 5 |
| −4 | K954987 | Altratouch 1000 Hemodialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1996 | 1 |
| −3 | K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1997 | 5 |
| −2 | K993064 | Prisma CFM (Continuous Fluid Management System) | Gambro Renal Care Products | 1999 | 1 |
| −1 | K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corp | 2002 | 3 |
| 0 (this device) | K070320 | Edwards Aquarius Hemofiltration System, Model Abm 01 | Edwards Lifesciences Services GmbH | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (5)
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 |
|---|---|---|---|
| * | K021615 | Baxter Accura System, Model 5M5660Summary page 3…Equivalence: The Edwards Aquarius system is based on product manufactured by MeSys, which has also been used as the basis for the Baxter Accura System - K021615. The Edwards Aquarius system has been marketed and developed in Europe for six years. The software has been significantly improv… | 2002 |
| * | K993064 | Prisma CFM (Continuous Fluid Management System)Summary page 3…The Edwards Aquarius system is substantially equivalent in design, use and materials to the: Baxter Accura System K021615 Gambro Prisma System K993064, K981681, K946279 B. Braun Diapact K973322 The Edwards Aquarius system is made of the same materials as the Bax… | 1999 |
| * | K981681 | Prisma CFM (Continuous Fluid Management System)Summary page 3…ards Aquarius system is substantially equivalent in design, use and materials to the: Baxter Accura System K021615 Gambro Prisma System K993064, K981681, K946279 B. Braun Diapact K973322 The Edwards Aquarius system is made of the same materials as the Baxter Accur… | 1998 |
| * | K946279 | Prisma CFM (Continuous Fluid Management System)Summary page 3…rius system is substantially equivalent in design, use and materials to the: Baxter Accura System K021615 Gambro Prisma System K993064, K981681, K946279 B. Braun Diapact K973322 The Edwards Aquarius system is made of the same materials as the Baxter Accura System… | 1997 |
| * | K973322 | Diapact CRRTSummary page 3…design, use and materials to the: Baxter Accura System K021615 Gambro Prisma System K993064, K981681, K946279 B. Braun Diapact K973322 The Edwards Aquarius system is made of the same materials as the Baxter Accura System (K021615). The Edwards Aquarius system is… | 1998 |
| † | K063293 | Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards… | 2007 |
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 |
|---|---|---|---|
| K090682 | Edwards Aquarius System, Model GE-F098-00 | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2009 | Not classified | Z-0653-2010 | Employee error | There have been reports of clinically significant fluid imbalance when a certain level of fluid imbalance is detected the Aquarius will trigger an alarm, however, users are able to override this alarm and continue therapy. It is possible… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 7 of the 17 ancestors have a recall of any class.
- Of its descendants, K090682 (Edwards Lifesciences Services GmbH, 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K021615.
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. 2007, 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/K070320 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070320: Edwards Aquarius Hemofiltration System, Model Abm 01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070320
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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