510(k) · Cleared

Recalled · 2009

Altratouch 1000 Hemodialysis Delivery System

K954987510(k) TraditionalCleared Aug 8, 1996282-day reviewClass II21 CFR 876.5860Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Althin Medical AB an Affiliate of Baxter Intl · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Aug 8, 1996 as substantially equivalent to K910215 (Cd Medical, Inc., 1991) after a 282-day review. Its family tree reaches back 1 generation to 1991. 13 later devices descend from it. It has been recalled once.

Decided: Aug 8, 1996
Review: 282 days
Class: Class II
Product code: KDI
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K910215 (1991). 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK910215 Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 1991 · Recalled
This deviceK954987 Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996
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 13 descendants. See all descendants

Descendants cleared per year

1997high 2 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 13 · 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	K910215	Drake Willock System 1000 Dialysate Delivery Syst	Cd Medical, Inc.	1991	5
0 (this device)	K954987	Altratouch 1000 Hemodialysis Delivery System	Althin Medical AB an Affiliate of Baxter Intl	1996	—
+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	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

FIG. 1 — Lineage of K954987, 1991–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K910215	Drake Willock System 1000 Dialysate Delivery Syst Summary page 2 …traTouch™ 1000 Single Patient Hemodialysis Delivery System is a modification of the Drake Willock® System 1000 Single Patient Dialysate Delivery System {510(k) number K910215}, the predicate machine. The modifications consist of: l.Replacing the 12 inch (diagonal) Cathode Ray Tube display of the predi…	Cd Medical, Inc.	1991	5

Also cleared against K910215: 3 other devices →

What descends from it? (13)

See all 13

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K970446	Drake Willock System & Altra Touch 1000 Dialysis Delivery System	Althin Medical AB an Affiliate of Baxter Intl	1997	11
K964922	Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery…	Althin Medical AB an Affiliate of Baxter Intl	1997	1
K013562	Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys…	Baxter Healthcare Corp	2002	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 31, 2009	Not classified	Z-0179-2010	Software design	When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's manual.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K970446 (Althin Medical AB an Affiliate of Baxter Intl, 1997) has gone furthest, with 11 descendants of its own.
3 other devices also cite its predicate K910215.

How does its category compare?

All KDI devices

KDI 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

2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007high 6,154 (2014) · low 522 (2009)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?

To provide hemodialysis treatment to patients with acute or chronic renal failure.

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/K954987 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954987: Altratouch 1000 Hemodialysis 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/K954987

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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