Cleared Traditional

K870801 - FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPI...

K870801 is the FDA 510(k) clearance for FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPI... by Travenol Laboratories, S.A.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K870801 · Travenol Laboratories, S.A. · General Hospital
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Sep 1987
Decision
189d
Days
Class 2
Risk

K870801 is an FDA 510(k) clearance for the FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 189 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K870801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1987
Decision Date September 04, 1987
Days to Decision 189 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 slower than avg
Panel avg: 129d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K870801.
IMED(R) 980C VOLUMETRIC INFUSION PUMP
K870656 · Imed Corp. · Oct 1987
NUTRIPUMP
K872741 · I M, Inc. · Oct 1987
ULTRASONIC AIR-IN-LINE DETECTOR (AILD)
K872952 · Imed Corp. · Oct 1987
RATE INFUSER SYSTEM
K872850 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1987
MODIFIED LIFECARE(R) 4100 PCA INFUSER
K871728 · Abbott Laboratories · Jul 1987
INFUSION PUMP ENCLOSURE
K872821 · Pharmacia Deltec, Inc. · Jul 1987