# K032789: Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door Assembly, P2, Model BX10469

- Pathway: 510(k) (Traditional)
- Applicant: American I.V. Products, Inc.
- Decided: Oct 9, 2003 after 31 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915522 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915522: Flo-Gard (R) 6201, Baxter Healthcare Corp (1992) Summary page 1.
- K915523: Flo-Gard (R) 6301, Baxter Healthcare Corp (1992) Summary page 1.

## Indications for use
These devices are intended to be used as replacement door assemblies for Baxter Flo-GardB 6201 and Baxter Flo-Gard@6301 volumetric infusion pumps, for use to deliver drug solutions, enteral feedings and blood.

Source page: https://510kreport.com/device/K032789
Methodology: https://510kreport.com/methodology