# K230632: VersiHD with GuideMe software

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Aug 11, 2023 after 157 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: 5 generations back to K093069 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170469: NxStage System One Plus, Nxstage Medical, Inc. (2017) Summary page 4.

## Indications for use
The NxStage system is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The system is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours. All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

Source page: https://510kreport.com/device/K230632
Methodology: https://510kreport.com/methodology