# K915523: Flo-Gard (R) 6301

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Feb 28, 1992 after 80 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K032789: Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door Assembly, P2, Model BX10469 (2003), 0 descendants of its own
- K973640: TS2000 Medical Device Monitor (1998), 0 descendants of its own

## Recalls of this device
- Aug 26, 2011 · Not classified · Z-0134-2012: The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test.
- Jun 21, 2007 · Not classified · Z-1112-2007: Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.
- Nov 27, 2006 · Not classified · Z-0633-2007: There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretr

Source page: https://510kreport.com/device/K915523
Methodology: https://510kreport.com/methodology