# K233557: HemoCare Hemodialysis System

- Pathway: 510(k) (Traditional)
- Applicant: Deka Research and Development
- Decided: Jul 12, 2024 after 249 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K921456 (1994). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub, Aksys, Ltd. (2002) Summary page 6.
- K210575: HDF Assist Mudule, HDF Infusion Set and Substitution Filter, Nephros (2022) Summary page 6.
- K141752: Nxstage System One, Nxstage Medical, Inc. (2014) Summary page 6.
- K211370: Tablo Hemodialysis System, Outset Medical, Inc. (2022) Summary page 6.

## Indications for use
The HemoCare® Hemodialysis System is indicated for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare Hemodialysis System is indicated for use in chronic dialysis facilities, self-care dialysis facilities, and the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed with the assistance or observation of an individual who has been trained and is considered competent in the use of the device. The HemoCare Hemodialysis System is not indicated for solo hemodialysis in the home setting.

Source page: https://510kreport.com/device/K233557
Methodology: https://510kreport.com/methodology