510(k) · Cleared

Recalled · 2006

PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub

K010131510(k) TraditionalCleared Mar 26, 2002434-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

Aksys, Ltd. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Mar 26, 2002 as substantially equivalent to K881270 (Gambro, Inc., 1988) and 10 other predicates after a 434-day review. Its family tree reaches back 1 generation to 1977. 12 later devices descend from it. It has been recalled once.

Decided: Mar 26, 2002
Review: 434 days
Class: Class II
Product code: KDI
Recalls: 1
Predicates: 11

Its longest line of descent runs back 1 generation to K770691 (1977). 11 ancestors in all. 12 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK770691 Gambro Venous Blood LineGambro, Inc. · 1977
This deviceK010131 PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment…Aksys, Ltd. · 2002
Descendant · cites it directly · 5 of its ownK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
Descendant · cites it directly · 5 of its ownK043436 Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005
Descendant · 2 generations on · 3 of its ownK060296 Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006
Descendant · cites it directly · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
Descendant · 3 generations on · 2 of its ownK080919 Nxstage Pureflow SLNxstage Medical, Inc. · 2008 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005high 2 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all

K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012 · cites it directly5descendants
K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005 · cites it directly5descendants
K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006 · 2 generations on3descendants
K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · cites it directly2descendants
K080919Nxstage Pureflow SLNxstage Medical, Inc. · 2008 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K770691	Gambro Venous Blood Line	Gambro, Inc.	1977	—
0 (this device)	K010131	PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment…	Aksys, Ltd.	2002	—
+1	K112314	Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter	Nephros, Inc.	2012	—
+1	K043436	Nxstage Dialysate Preparation Module, Model NX0269	Nxstage Medical, Inc.	2005	—
+2	K060296	Nxstage Dialysate Preparation Module	Nxstage Medical, Inc.	2006	—
+1	K231534	5008X Hemodialysis System	Fresenius Medical Care	2024	1
+3	K080919	Nxstage Pureflow SL	Nxstage Medical, Inc.	2008	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1984	1	0
1987	1	0
1988	2	0
1989	2	0
1990	1	0
1994	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2008	2	0
2011	1	0
2012	1	0
2014	1	0
2022	1	0
2024	2	0
2025	2	0

FIG. 1 — Lineage of K010131, 1977–2025Source: 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? (12)

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
*	K881270	Gambro Multipurpose System MPS-10 Summary page 1 …tion system for hemodialysis (per 21 CRF 876.5665) SUBSTANTIALLY EQUIVALENT DEVICES: Hemaodialysis Delivery Systems 1. Gambro Multipurpose System MPS-10 Gambro, Inc. (K881270) 2. Fresenius 2008 Touch Panel Contirol Dialysis System Fresenius USA, Inc. (K890824) 3. RSP® Hemodialysis Machine Travenol Lab…	Gambro, Inc.	1988	—
*	K890824	Fresenius 2008 Touch Panel Control Dialysis System Summary page 1 …Hemaodialysis Delivery Systems 1. Gambro Multipurpose System MPS-10 Gambro, Inc. (K881270) 2. Fresenius 2008 Touch Panel Contirol Dialysis System Fresenius USA, Inc. (K890824) 3. RSP® Hemodialysis Machine Travenol Laboratories, Inc, (Pre-Amendment) Reuse Equipment for Hemeodialysis 4. HR 3000 Home Pat…	Fresenius USA, Inc.	1989	—
*	K841153	Adaptor HR-3000 Reuse Summary page 1 …® Hemodialysis Machine Travenol Laboratories, Inc, (Pre-Amendment) Reuse Equipment for Hemeodialysis 4. HR 3000 Home Patient Reprocessing Device Colorado Medical, Inc. (K841153) S, K‘egatron II Dialyzer Reprocessing System Minntech Corp. (K904210) 510(K) SUMMARY: PHD™ PERSONAL HEMODIALYSIS SYSTEM PAGE \|…	Colorado Medical, Inc.	1984	—
*	K904210	Renatron II Dialyzer Reprocessing System RS 8330 Summary page 1 …e Equipment for Hemeodialysis 4. HR 3000 Home Patient Reprocessing Device Colorado Medical, Inc. (K841153) S, K‘egatron II Dialyzer Reprocessing System Minntech Corp. (K904210) 510(K) SUMMARY: PHD™ PERSONAL HEMODIALYSIS SYSTEM PAGE \| PREMARKET NOTIFICATION FOR THE AKSYS PHD SYSTEM Water…	Minntech Corp.	1990	—
*	K811678	Gambro Water Purification Monitor WRD Summary page 2 …PREMARKET NOTIFICATION FOR THE AKSYS PHD SYSTEM Water Purification Systems for Hemodialysis 6. Gambro WRO 10-01 Water Purification Monitor Gambro, Inc. (K811678) 7. ZyzaTech Series Reverse Osmosis Systems ZyzaTech Water Systems, Inc. (K964539) Arterial-Venous Blood Tubing Sets for Hemodi…	Gambro, Inc.	1981	—
*	K964539	Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802… Summary page 2 …Systems for Hemodialysis 6. Gambro WRO 10-01 Water Purification Monitor Gambro, Inc. (K811678) 7. ZyzaTech Series Reverse Osmosis Systems ZyzaTech Water Systems, Inc. (K964539) Arterial-Venous Blood Tubing Sets for Hemodialysis 8. Gambro Venous Blood Line Gambro, Inc. (K770691) 9. Erika Mode] 9608 Art…	Zyzatech Water Systems, Inc.	1997	—
*	K770691	Gambro Venous Blood Line Summary page 2 …Tech Series Reverse Osmosis Systems ZyzaTech Water Systems, Inc. (K964539) Arterial-Venous Blood Tubing Sets for Hemodialysis 8. Gambro Venous Blood Line Gambro, Inc. (K770691) 9. Erika Mode] 9608 Arterial Blood Line National Medical Care, Inc. (K870722) Dialysate Chemical Concentrates 10. Hemodialysi…	Gambro, Inc.	1977	—
*	K870722	Label CHG for Erika Model 9608 Arterial Blood Line Summary page 2 …erial-Venous Blood Tubing Sets for Hemodialysis 8. Gambro Venous Blood Line Gambro, Inc. (K770691) 9. Erika Mode] 9608 Arterial Blood Line National Medical Care, Inc. (K870722) Dialysate Chemical Concentrates 10. Hemodialysis Bath Concentrate Solutions for Hemodialysis. Dial Medical of Florida, Inc. (K…	National Medical Care, Medical Products Div., Inc.	1988	—
*	K864265	Hemodialysis Bath Concentrate Solutions for Hemodi Summary page 2 …Line National Medical Care, Inc. (K870722) Dialysate Chemical Concentrates 10. Hemodialysis Bath Concentrate Solutions for Hemodialysis. Dial Medical of Florida, Inc. (K864265) 11. Liquiflo™ and Biocarb™ Dry Bicarbonate Concentrates Fresenivs USA, Inc. (K896111) Transducer Protectors 12. Dualex® Trans…	Dial Medical of Florida, Inc.	1987	—
*	K896111	Fresenius Biocarb Hemodialysis Grade Sodium Bicarb Summary page 2 …alysis Bath Concentrate Solutions for Hemodialysis. Dial Medical of Florida, Inc. (K864265) 11. Liquiflo™ and Biocarb™ Dry Bicarbonate Concentrates Fresenivs USA, Inc. (K896111) Transducer Protectors 12. Dualex® Transducer Protector Millipore Corporation (K934069) DEVICE DESCRIPTION: The PHD® Personal…	Fresenius USA, Inc.	1989	—
*	K934069	Millex, Dualex (Plus, Ultra) Summary page 2 …5) 11. Liquiflo™ and Biocarb™ Dry Bicarbonate Concentrates Fresenivs USA, Inc. (K896111) Transducer Protectors 12. Dualex® Transducer Protector Millipore Corporation (K934069) DEVICE DESCRIPTION: The PHD® Personal Hemodialysis System is an automated high flux hemodialysis systetn using & double needls…	Millipore Corp.	1994	—
*	—	RSP® Hemodialysis Machine Named without a submission number			—

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K112314	Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter	Nephros, Inc.	2012	5
K043436	Nxstage Dialysate Preparation Module, Model NX0269	Nxstage Medical, Inc.	2005	5
K231534	5008X Hemodialysis System	Fresenius Medical Care	2024	2
K233557	HemoCare Hemodialysis System	Deka Research and Development	2024	0
K081043	Leak Detection Sensor and Tray Accessory Kit	Nxstage Medical, Inc.	2008	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 26, 2006	Not classified	Z-1239-06	Other	The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 11 ancestors has a recall.
Of its descendants, K112314 (Nephros, Inc., 2012) has gone furthest, with 5 descendants of its own.

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?

Indicated for the treatment of the chronic or acute uremic patient where hemodialysis, including high flux dialysis, is prescribed by the physician.

Indicated for hemodialysis in a variety of environments, to include acute care facility, chronic dialysis facility, self care facility, or home setting, where the operator has been trained and certified to be competent in the use of this device by the attending physician.

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/K010131 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010131

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026