510(k) · Cleared
Recalled · 2011Drake Willock System & Altra Touch 1000 Dialysis 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 Jun 2, 1997 as substantially equivalent to K910215 (Cd Medical, Inc., 1991) and 5 other predicates after a 117-day review. Its family tree reaches back 2 generations to 1991. 11 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 2, 1997
- Review
- 117 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 5
- Predicates
- 6
Its longest line of descent runs back 2 generations to K910215 (1991). 7 ancestors in all, the oldest K873279 (1987). 11 later devices descend from it, 2 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 deviceK970446 Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997
- Descendant · cites it directly · 9 of its ownK993064 Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · Recalled
- Descendant · 2 generations on · 8 of its ownK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · Recalled
- Descendant · 3 generations on · 4 of its ownK041005 Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · Recalled
- Descendant · 4 generations on · 1 of its ownK080519 Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK070320 Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH · 2007 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K993064Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · cites it directly9descendants
- K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · 2 generations on8descendants
- K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004 · 3 generations on4descendants
- K080519Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · 4 generations on1descendant
- K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH · 2007 · 2 generations on1descendant
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) | K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | 1997 | — |
| +1 | K993064 | Prisma CFM (Continuous Fluid Management System) | Gambro Renal Care Products | 1999 | 1 |
| +2 | K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corp | 2002 | 3 |
| +3 | K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets | Gambro Renal Products | 2004 | 7 |
| +4 | K080519 | Prismaflex M150 Set | Gambro Renal Products, Inc. | 2008 | 3 |
| +2 | K070320 | Edwards Aquarius Hemofiltration System, Model Abm 01 | Edwards Lifesciences Services GmbH | 2007 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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…on: The Hematocrit and Blood Volume (HCT/BV) Monitor feature is a modification to the predicate System 1000®/AltraTouch™ 1000 dialysis delivery system [510(k) numbers * K910215 System 1000® Dialysis Delivery System, K954987 AltraTouch™ 1000 machine and K955384 SND option.] that integrates the stand-alone… | 1991 |
| * | K954987 | Altratouch 1000 Hemodialysis Delivery SystemSummary page 1…onitor feature is a modification to the predicate System 1000®/AltraTouch™ 1000 dialysis delivery system [510(k) numbers * K910215 System 1000® Dialysis Delivery System, K954987 AltraTouch™ 1000 machine and K955384 SND option.] that integrates the stand-alone Crit-Line™ II Instrument for measuring hematoc… | 1996 |
| * | K955384 | Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen OptionSummary page 1…e predicate System 1000®/AltraTouch™ 1000 dialysis delivery system [510(k) numbers * K910215 System 1000® Dialysis Delivery System, K954987 AltraTouch™ 1000 machine and K955384 SND option.] that integrates the stand-alone Crit-Line™ II Instrument for measuring hematocrit (Hct), percent blood volume change… | 1997 |
| * | K924167 | Crit-LineSummary page 1…nd-alone Crit-Line™ II Instrument for measuring hematocrit (Hct), percent blood volume change (ABV), oxygen saturation (O, Sat) and access recirculation [510(k) numbers K924167 Crit-Line I with Blood Chamber, K935958 Blood Chamber with E-Beam, K950942 Crit-Line II with Hematocrit Alarm feature and K95387… | 1993 |
| * | K950942 | Crit-Line Hematocrit AlertSummary page 1…lood volume change (ABV), oxygen saturation (O, Sat) and access recirculation [510(k) numbers K924167 Crit-Line I with Blood Chamber, K935958 Blood Chamber with E-Beam, K950942 Crit-Line II with Hematocrit Alarm feature and K953875 Crit-Line II with Access Recirculation feature.] into the dialysis deliv… | 1995 |
| * | K953875 | Crit-Line Hematocrit Alert (Modification)Summary page 1…d access recirculation [510(k) numbers K924167 Crit-Line I with Blood Chamber, K935958 Blood Chamber with E-Beam, K950942 Crit-Line II with Hematocrit Alarm feature and K953875 Crit-Line II with Access Recirculation feature.] into the dialysis delivery system. The primary reason for making the modificat… | 1996 |
| † | K935958 | Crit-Line Blood Chamber with E-Beam | 1995 |
What descends from it? (11)
See all 112 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 |
|---|---|---|---|---|
| Sep 19, 2011 | Not classified | Z-0173-2012 | Employee error | The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test. |
| 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. |
| Jun 14, 2005 | Not classified | Z-1394-05 | Other | Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Advise, and Bicarbonate Value… |
| Dec 14, 2004 | Not classified | Z-0367-05 | Other | Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism. |
| Feb 20, 2004 | Not classified | Z-0583-04 | Other | These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire. |
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 7 ancestors have a recall of any class.
- Of its descendants, K993064 (Gambro Renal Care Products, 1999) has gone furthest, with 9 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 intended use of the device is 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 use in conjunction with a hollow fiber or parallel plate dialyzer. The intended use of this device is to monitor Hematocrit, Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation.…
Read the full statement (153 words)
The intended use of the device is 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 use in conjunction with a hollow fiber or parallel plate dialyzer.
The intended use of this device is to monitor Hematocrit, Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation.
The device is intended to be used as an integrated option of the System 1000° Dialysis Delivery System.
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 the Crit-Line disposable Blood Chamber. The Blood Chamber is a non reusable device.
To provide the medical professional with a means of monitoring Hematocrit, Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation during hemodialysis treatment.
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/K970446 · printed Nov 3, 2026
Cite this page
510(k) Report. “K970446: Drake Willock System & Altra Touch 1000 Dialysis Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K970446
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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