Cleared Traditional

K870801 - FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD

K870801 is an FDA 510(k) clearance for FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPI..., manufactured by Travenol Laboratories, S.A.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K870801

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.

FRN Device Classification - Class 2, Special Controls

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 582
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