# K872364: Hemodialysis (SPS), Model 550, Code 5M1309

- Pathway: 510(k) (Traditional)
- Applicant: Travenol Laboratories, S.A.
- Decided: Oct 13, 1987 after 117 days
- Product code: FII (System, Dialysate Delivery, Sealed)
- Device class: 2
- Regulation: 21 CFR 876.5860
- 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.
30 later devices descend from it; 1 cites it directly.
0 of 31 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
- K030470: Nxstage System One (2003), 29 descendants of its own
- K041424: Nxstage System One (2004), 28 descendants of its own
- K050525: Nxstage System One (2005), 27 descendants of its own
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 (2006), 26 descendants of its own
- K083778: Xenium XPH, Models 110, 130, 150, 170, 190 and 210 (2009), 20 descendants of its own

## Recalls of this device
- Dec 14, 2004 · Not classified · Z-0367-05: Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism.
- Feb 20, 2003 · Not classified · Z-0660-03: Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)

Source page: https://510kreport.com/device/K872364
Methodology: https://510kreport.com/methodology