Flo-Gard 4000 Volumetric Infusion Controller

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854863 ↗

FDA Product Code

LDR

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 primary function of the Flo-Gard 4000?

  The Flo-Gard 4000 is an electronic, intravascular infusion controller designed to regulate the delivery of fluids into the vascular system within general hospital settings.

• What is the regulatory status of this device?

  The Flo-Gard 4000 is a Class II medical device under regulation number 880.5725. It received FDA 510(k) clearance under submission number K854863, confirming it is substantially equivalent to legally marketed predicate devices.

• In what clinical environment is this controller used?

  This device is intended for use in general hospital settings, as indicated by its classification under the General Hospital advisory committee.