Cleared Traditional

K854863 - FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER

K854863 is an FDA 510(k) clearance for FLO-GARD 4000 VOLUMETRIC INFUSION CONTR..., manufactured by Travenol Laboratories, S.A.. The device is a Class 2 General Hospital device with product code LDR cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K854863 · Travenol Laboratories, S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
69d
Days
Class 2
Risk

K854863 is an FDA 510(k) clearance for the FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on February 12, 1986 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K854863

510(k) Number K854863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1985
Decision Date February 12, 1986
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDR Device Classification - Class 2, Special Controls

Product Code LDR Controller, Infusion, Intravascular, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LDR Controller, Infusion, Intravascular, Electronic

All 59
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K854863.
STA-SET MODEL 250 I.V. FLOW REGULATOR
K864229 · Sta-Set Corp. · Dec 1986
DEKA JR.
K863204 · Deka Research & Development Corp. · Sep 1986
BETAFLO 2000
K862273 · Betaflo, Inc. · Jul 1986
RATEMINDER III INFUSION DEVICE
K855000 · American Edwards Laboratories · Feb 1986
DOSI FLOW
K851058 · Leventon, S.A. · Apr 1985
ARM-A-FLOW INTRAVENOUS FLOW REGULATOR
K842209 · Armour Pharmaceutical Co. · Dec 1984
K854863 · FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
Download PDF Travenol Laboratories…