510(k) · Cleared
Recalled · 2005Baxter Accura System, Model 5M5660
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 Nov 18, 2002 as substantially equivalent to K993064 (Gambro Renal Care Products, 1999) and 4 other predicates after a 186-day review. Its family tree reaches back 4 generations to 1991. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 18, 2002
- Review
- 186 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 4 generations to K910215 (1991). 16 ancestors in all, the oldest K873279 (1987). 8 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK910215 Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 1991 · Recalled
- 3 generations backK954987 Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996 · Recalled
- 2 generations backK970446 Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · Recalled
- 1 generation backK993064 Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · Recalled
- This deviceK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002
- Descendant · cites it directly · 4 of its ownK041005 Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · Recalled
- Descendant · 2 generations on · 1 of its ownK080519 Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · Recalled
- Descendant · cites it directly · 1 of its ownK070320 Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK042938 Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005 · Recalled
- Descendant · 3 generations on · 0 of its ownK220281 multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · cites it directly4descendants
- K080519Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · 2 generations on1descendant
- K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH · 2007 · cites it directly1descendant
- K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005 · 2 generations on1descendant
- K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910215 | Drake Willock System 1000 Dialysate Delivery Syst | Cd Medical, Inc. | 1991 | 5 |
| −3 | K954987 | Altratouch 1000 Hemodialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1996 | 1 |
| −2 | K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1997 | 5 |
| −1 | K993064 | Prisma CFM (Continuous Fluid Management System) | Gambro Renal Care Products | 1999 | 1 |
| 0 (this device) | K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corp | 2002 | — |
| +1 | K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | Gambro Renal Products | 2004 | 7 |
| +2 | K080519 | Prismaflex M150 Set | Gambro Renal Products, Inc. | 2008 | 3 |
| +1 | K070320 | Edwards Aquarius Hemofiltration System, Model Abm 01 | Edwards Lifesciences Services GmbH | 2007 | 1 |
| +2 | K042938 | Gambro Prismaflex HF1000 and HF1400 Sets | Gambro Renal Products | 2005 | 7 |
| +3 | K220281 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K993064 | Prisma CFM (Continuous Fluid Management System)Summary page 1…stem for Continuous Renal Replacement Therapy Classification Name: High Permeability Hemodialysis System per 21 CFR 876.5860 Equivalent Predicate: PFUSMATMSystem (K993064, K98168 1,K946279) Diapact CRRT (K973322) Bml 1 Blood Monitor Pump Disposable Tub… | 1999 |
| * | K981681 | Prisma CFM (Continuous Fluid Management System)Summary page 1…Continuous Renal Replacement Therapy Classification Name: High Permeability Hemodialysis System per 21 CFR 876.5860 Equivalent Predicate: PFUSMATMSystem (K993064, K98168 1,K946279) Diapact CRRT (K973322) Bml 1 Blood Monitor Pump Disposable Tubing Set… | 1998 |
| * | K946279 | Prisma CFM (Continuous Fluid Management System)Summary page 1…s Renal Replacement Therapy Classification Name: High Permeability Hemodialysis System per 21 CFR 876.5860 Equivalent Predicate: PFUSMATMSystem (K993064, K98168 1,K946279) Diapact CRRT (K973322) Bml 1 Blood Monitor Pump Disposable Tubing Set… | 1997 |
| * | K973322 | Diapact CRRTSummary page 1…e: High Permeability Hemodialysis System per 21 CFR 876.5860 Equivalent Predicate: PFUSMATMSystem (K993064, K98168 1,K946279) Diapact CRRT (K973322) Bml 1 Blood Monitor Pump Disposable Tubing Set (K9 113 15/A) Device Description… | 1998 |
| * | K911315 | Extracorporeal Blood Pumping Syst for HemofiltratSummary page 1…K993064, K98168 1,K946279) Diapact CRRT (K973322) Bml 1 Blood Monitor Pump Disposable Tubing Set (K9 113 15/A) Device Description: The Accura System hardware consists of blood pumps, scales and various monito… | 1991 |
What descends from it? (8)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2005 | Not classified | Z-0153-06 | Other | A software anomaly that occurs when the Reset Totals option is selected during CVVHD therapy with a diaylsate flow rate of less than 600 mL/hour, or CVVH therapy with a predilution flow rate of less than 600 mL/hour, causes balance alarms… |
| Jul 13, 2005 | Not classified | Z-1380-05 | Device Design | In the event therapy is terminated, as part of routine instrument programming or therapy maintenance, the Accura instrument may experience difficulty in performing a successful self-test (failure) upon an immediate attempt to restart… |
| Jul 26, 2004 | Not classified | Z-1338-04 | Other | The Accura machine display screen may go blank during patient treatment. There is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen, which could affect the current… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 6 of the 16 ancestors have a recall of any class.
- Of its descendants, K041005 (Gambro Renal Products, 2004) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K993064.
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 Baxter Accura System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Baxter Accura System may also be used in Therapeutic Plasma Exchange (TPE) therapies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021615 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021615: Baxter Accura System, Model 5M5660.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021615
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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