# K883111: Heomdialysis Single Patient System (SPS) Model 650

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Feb 8, 1989 after 198 days
- Product code: FKP (System, Dialysate Delivery, Single Patient)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992894: Meridian Hemodialysis Machine, Model 5M5576 (1999), 2 descendants of its own
- K053539: Meridian Hemodialysis Machine, Model 5M5576 (2006), 0 descendants of its own
- K013562: Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys 1000, L3 with N100 Arm, 4B Software (2002), 0 descendants of its own

## Recalls of this device
- Jan 29, 2010 · Not classified · Z-1322-2010: Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.
- Feb 20, 2003 · Not classified · Z-0661-03: Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)

Source page: https://510kreport.com/device/K883111
Methodology: https://510kreport.com/methodology