510(k) · Cleared
ClearedDrake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System
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 May 21, 1997 as substantially equivalent to K910215 (Cd Medical, Inc., 1991) and 1 other predicate after a 163-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- May 21, 1997
- Review
- 163 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910215 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK910215 Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 1991 · Recalled
- 1 generation backK954987 Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996 · Recalled
- This deviceK964922 Drake Willock System 1000 Dialysate Delivery System Altratouch 1000…Althin Medical AB an Affiliate of Baxter Intl · 1997
- Descendant · cites it directly · 0 of its ownK013562 Aurora System 1000 Series Home Self-Care Single Patient Delivery…Baxter Healthcare Corp · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K013562Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys…Baxter Healthcare Corp · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910215 | Drake Willock System 1000 Dialysate Delivery Syst | Cd Medical, Inc. | 1991 | 5 |
| −1 | K954987 | Altratouch 1000 Hemodialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1996 | 1 |
| 0 (this device) | K964922 | Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate… | Althin Medical AB an Affiliate of Baxter Intl | 1997 | — |
| +1 | K013562 | Aurora System 1000 Series Home Self-Care Single Patient Delivery System… | Baxter Healthcare Corp | 2002 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K910215 | Drake Willock System 1000 Dialysate Delivery SystSummary page 1…tion / Comparison to Predicate Device: The AutoStart feature is a modification to predicate System 1000® and AluaTouch™ 1000 Dialysate Delivery Systems [S10(k) numbers K910215 and K954987.) The System Y 1000® and AltraTouch™ 1000 single patient hemodialysis delivery systems with the Auto Start option ar… | 1991 |
| * | K954987 | Altratouch 1000 Hemodialysis Delivery SystemSummary page 1…rison to Predicate Device: The AutoStart feature is a modification to predicate System 1000® and AluaTouch™ 1000 Dialysate Delivery Systems [S10(k) numbers K910215 and K954987.) The System Y 1000® and AltraTouch™ 1000 single patient hemodialysis delivery systems with the Auto Start option are built with… | 1996 |
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 |
|---|---|---|---|
| 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)
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 6 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K013562 (Baxter Healthcare Corp, 2002) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K910215.
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 indications for use of the device are to provide hemodialysis treatments in the acute and chronic setting including high flux hemodialysis.
The device is intended to be used by trained operators when prescribed by a physician.
The device is intended to be used in conjunction with a hollow fiber or parallel plate dialyzer.
The auto start option is intended to allow up to a three day delayed start of the fluid path heat clean or rinse cycle.
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/K964922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964922: Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964922
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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