Flo-Gard 6100 Volumetric Infusion Pump

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831258 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Burette Set with Air Control Lever

  Class II

  FDA 510(k) K780970 Active Cleared 27 Jul 1978

• Sterile Water & Saline in Plastic Btl.

  Class II

  FDA 510(k) K800753 Active Cleared 24 Apr 1980

• Solution Administration Sets

  Class II

  FDA 510(k) K860272 Active Cleared 18 Mar 1986

• Arteoial Blood Sampling Kit 2D9014

  Class II

  FDA 510(k) K771584 Active Cleared 13 Sep 1977

• Blood-Solution Administration Set, Surg.

  Class I

  FDA 510(k) K760483 Active Cleared 3 Sep 1976

• Flo-Gard 8000 Computer Control Infusi

  Class II

  FDA 510(k) K834154 Active Cleared 25 Jan 1984

See all devices from Travenol Laboratories, S.A. →

• What is the Flo-Gard 6100 Infusion Pump used for?

  The Flo-Gard 6100 Infusion Pump is used to pump fluids into a patient in a controlled manner, typically in a hospital setting.

• Is the Flo-Gard 6100 Infusion Pump supplied sterile?

  The device data does not specify if the Flo-Gard 6100 Infusion Pump is supplied sterile, it is intended for use in a controlled environment.

• What is the regulatory classification of the Flo-Gard 6100 Infusion Pump?

  The Flo-Gard 6100 Infusion Pump is classified as a Pump, Infusion, with a device class of 2 and a regulation number of 880.5725.