510(k) · Cleared
ClearedDrake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Althin Medical AB an Affiliate of Baxter Intl · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jan 10, 1997 as substantially equivalent to K873279 (Cd Medical, Inc., 1987) after a 415-day review. Its family tree reaches back 1 generation to 1987. 12 later devices descend from it.
- Decided
- Jan 10, 1997
- Review
- 415 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K873279 (1987). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK873279 8810 Pump-Pump Single Needle DeviceCd Medical, Inc. · 1987
- This deviceK955384 Drake Willock System 1000 Dialysate Delivery System W/Single Needle…Althin Medical AB an Affiliate of Baxter Intl · 1997
- 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
- Descendant · 5 generations on · 1 of its ownK080519 Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- 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
- K080519Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873279 | 8810 Pump-Pump Single Needle Device | Cd Medical, Inc. | 1987 | — |
| 0 (this device) | K955384 | Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single… | Althin Medical AB an Affiliate of Baxter Intl | 1997 | — |
| +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 |
| +5 | K080519 | Prismaflex M150 Set | Gambro Renal Products, Inc. | 2008 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 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), 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? (4)
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 |
|---|---|---|---|
| * | K873279 | 8810 Pump-Pump Single Needle DeviceSummary page 1…bstantially equivalent to the following products, which are currently legally marketed medical devices. 1. Drake Willock 8810 Single Needle Device Althin Medical, Inc. (K873279) 2. Drake Willock 8806 Single Needle Device Althin Medical, Inc. 3. Fresenius A 2008 D Single Needle Device Fresénius,USA 4.… | 1987 |
| * | — | Drake Willock 8806 Single Needle Device Named without a submission number | |
| * | — | Fresenius A 2008 D Single Needle Device Named without a submission number | |
| * | — | Hospal BSM 22 Named without a submission number |
What descends from it? (12)
See all 122 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K970446 (Althin Medical AB an Affiliate of Baxter Intl, 1997) has gone furthest, with 11 descendants of its own.
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?
Single Needle Single Lumen Dialysis is indicated for use when a single venipuncture is chosen for use in chronic or acute hemodialysis treatments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955384: Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955384
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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