510(k) · Cleared
Recalled · 2006Drake Willock System 1000 Dialysate Delivery Syst
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cd Medical, Inc. · FKP System, Dialysate Delivery, Single Patient
Cleared on Apr 9, 1991 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 9, 1991
- Review
- 82 days
- Class
- Class II
- Product code
- FKP
- Recalls
- 5
- Predicates
- 0
14 later devices descend from it, 4 citing it directly.
- This deviceK910215 Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 1991
- Descendant · cites it directly · 13 of its ownK954987 Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996 · Recalled
- Descendant · cites it directly · 11 of its ownK970446 Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · Recalled
- Descendant · 2 generations on · 9 of its ownK993064 Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · Recalled
- Descendant · 3 generations on · 8 of its ownK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · Recalled
- Descendant · 4 generations on · 4 of its ownK041005 Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K954987Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996 · cites it directly13descendants
- K970446Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · cites it directly11descendants
- K993064Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · 2 generations on9descendants
- K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · 3 generations on8descendants
- K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910215 | Drake Willock System 1000 Dialysate Delivery Syst | Cd Medical, Inc. | 1991 | — |
| +1 | K954987 | Altratouch 1000 Hemodialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1996 | 1 |
| +1 | 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 |
| +3 | K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corp | 2002 | 3 |
| +4 | K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | Gambro Renal Products | 2004 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FKP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K954987 | Altratouch 1000 Hemodialysis Delivery System | 1996 | 13 |
| K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery System | 1997 | 11 |
| K964922 | Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery… | 1997 | 1 |
| K013562 | Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys… | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 21, 2006 | Not classified | Z-1253-06 | Other | The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy. |
| Feb 24, 2006 | Not classified | Z-0766-06 | Other | The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts become cracked during patient treatment… |
| 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. |
| May 28, 2003 | Not classified | Z-0395-05 | Other | The air detector may not detect air bubbles consistently at the selected limit. |
| Mar 20, 2003 | Not classified | Z-0833-03 | Other | The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K954987 (Althin Medical AB an Affiliate of Baxter Intl, 1996) has gone furthest, with 13 descendants of its own.
How does its category compare?
All FKP devicesFKP System, Dialysate Delivery, Single Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FKP
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · FKP
Too few FKP 510(k)s in any year since 2007 to give a median.
Recalls per year · FKP
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FKP
4in 2021
MAUDE reports naming product code FKP, 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 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 4 | 26 |
| 2009 | 0 | — | 2 | 22 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K910215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910215: Drake Willock System 1000 Dialysate Delivery Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910215
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026