Cleared Traditional

K834154 - FLO-GARD 8000 COMPUTER CONTROL INFUSI

K834154 is an FDA 510(k) clearance for FLO-GARD 8000 COMPUTER CONTROL INFUSI, 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 54-day FDA review.

K834154 · Travenol Laboratories, S.A. · General Hospital
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Jan 1984
Decision
54d
Days
Class 2
Risk

K834154 is an FDA 510(k) clearance for the FLO-GARD 8000 COMPUTER CONTROL INFUSI. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1984 after a review of 54 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.

View all Travenol Laboratories, S.A. devices

FDA 510(k) Submission Details - K834154

510(k) Number K834154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1983
Decision Date January 25, 1984
Days to Decision 54 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
75d faster than avg
Panel avg: 129d · This submission: 54d
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 32
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K834154.
FLO-GARD 4000 VOLUMETRIC INFUSION
K840644 · Travenol Laboratories, S.A. · Mar 1984
TREONIC C30
K840823 · Vickers America Medical Corp. · Mar 1984
MODEL 2001 INTELLIGENT INFUSOR
K834528 · Quest Medical, Inc. · Feb 1984
KOALA C99 I.V. CONTROLLER
K830780 · Chesebrough-Pond'S U.S.A. Co. · Apr 1983
VOLUMERIC CONTROLLER
K823404 · Quest Medical, Inc. · Dec 1982
380 PIGGYBACK CONTROLLER
K823026 · Imed Corp. · Nov 1982