# K992894: Meridian Hemodialysis Machine, Model 5M5576

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 24, 1999 after 89 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883111 (1989). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883111: Heomdialysis Single Patient System (SPS) Model 650, Baxter Healthcare Corp (1989) Summary page 1.
- K922757: SPS 1550 Single Needle Patient System, Baxter Healthcare Corp (1995) Summary page 1.

## Most influential descendants
- 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
- Sep 6, 2006 · Not classified · Z-0169-2007: The Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring.
- Sep 28, 2005 · Not classified · Z-0275-06: Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a d
- Dec 2, 2004 · Not classified · Z-0299-05: The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.
- Mar 10, 2004 · Not classified · Z-0758-04: Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian.
- Oct 3, 2003 · Not classified · Z-0947-05: The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.

## Indications for use
The Baxter Meridian machine is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient’s blood, an extracorporeal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control. standard and variable bicarbonate and sodium capabilities and automated chemical disinfection, The Meridian machine will operate in either the bicarbonate or acetate mode for concentrates, The Meridian Hemodialysis Machine is designed to operate in the chronic and acute dialysis environment.

Source page: https://510kreport.com/device/K992894
Methodology: https://510kreport.com/methodology