Cleared Traditional

K831258 - FLO-GARD 6100 VOLUMETRIC INFUSION PUMP

K831258 is the FDA 510(k) clearance for FLO-GARD 6100 VOLUMETRIC INFUSION PUMP 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 73-day FDA review.

K831258 · Travenol Laboratories, S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
73d
Days
Class 2
Risk

K831258 is an FDA 510(k) clearance for the FLO-GARD 6100 VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 73 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

Submission Details

510(k) Number K831258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date June 30, 1983
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 K831258.
INFUTROL 7000 INFUSION PUMP
K832008 · Valleylab, Inc. · Aug 1983
PROMINJET PUMP
K832120 · Abbott Laboratories · Aug 1983
ENTERNAL PUMP & ADMIN. SET 430
K831935 · Imed Corp. · Aug 1983
Y-TYPE BACKCHECK MICROBORE EXTEN. SET
K831203 · Abbott Laboratories · Jun 1983
RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE
K831259 · Cardiac Pacemakers, Inc. · May 1983
PCA PUMP
K830452 · Abbott Laboratories · Apr 1983