# K915522: Flo-Gard (R) 6201

- 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 5 cite it directly.
6 of 22 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
- K972678: Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration Sets (1997), 16 descendants of its own
- K062700: Infusomat Space Volumetric Infusion Pump System (2006), 15 descendants of its own
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K083689: Infusomat Space Volumetric Infusion Pump System (2009), 4 descendants of its own
- K170595: IV Administration Sets (2017), 3 descendants of its own

## Recalls of this device
- Mar 24, 2011 · Not classified · Z-2122-2011: Pumps submitted for service may not have been properly serviced before being returned to the customer.
- Nov 17, 2010 · Not classified · Z-0933-2011: The FloGard Infusion Pump was released from service without having the Current Leakage test performed. This could lead to the patient/user to receive an electrical shock.
- Jun 21, 2007 · Not classified · Z-1111-2007: 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-0632-2007: 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
- May 3, 2005 · Not classified · Z-1552-05: The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis.
- May 3, 2005 · Not classified · Z-1553-05: The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis.

Source page: https://510kreport.com/device/K915522
Methodology: https://510kreport.com/methodology