# K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub

- Pathway: 510(k) (Traditional)
- Applicant: Aksys, Ltd.
- Decided: Mar 26, 2002 after 434 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K770691 (1977). 11 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881270: Gambro Multipurpose System MPS-10, Gambro, Inc. (1988) Summary page 1.
- K890824: Fresenius 2008 Touch Panel Control Dialysis System, Fresenius USA, Inc. (1989) Summary page 1.
- K841153: Adaptor HR-3000 Reuse, Colorado Medical, Inc. (1984) Summary page 1.
- K904210: Renatron II Dialyzer Reprocessing System RS 8330, Minntech Corp. (1990) Summary page 1.
- K811678: Gambro Water Purification Monitor WRD, Gambro, Inc. (1981) Summary page 2.
- K964539: Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802, RO Secura, Reverse Osmosis Syst, Zyzatech Water Systems, Inc. (1997) Summary page 2.
- K770691: Gambro Venous Blood Line, Gambro, Inc. (1977) Summary page 2.
- K870722: Label CHG for Erika Model 9608 Arterial Blood Line, National Medical Care, Medical Products Div., Inc. (1988) Summary page 2.
- K864265: Hemodialysis Bath Concentrate Solutions for Hemodi, Dial Medical of Florida, Inc. (1987) Summary page 2.
- K896111: Fresenius Biocarb Hemodialysis Grade Sodium Bicarb, Fresenius USA, Inc. (1989) Summary page 2.
- K934069: Millex, Dualex (Plus, Ultra), Millipore Corp. (1994) Summary page 2.
- (no number) RSP® Hemodialysis Machine: named in the summary without a submission number

## Most influential descendants
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter (2012), 5 descendants of its own
- K043436: Nxstage Dialysate Preparation Module, Model NX0269 (2005), 5 descendants of its own
- K060296: Nxstage Dialysate Preparation Module (2006), 3 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K080919: Nxstage Pureflow SL (2008), 2 descendants of its own

## Recalls of this device
- Jun 26, 2006 · Not classified · Z-1239-06: The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.

## Indications for use
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.

Source page: https://510kreport.com/device/K010131
Methodology: https://510kreport.com/methodology