Cleared Traditional

K832166 - FLO-GARD 8500 MICROINFUSION PUMP

K832166 is the FDA 510(k) clearance for FLO-GARD 8500 MICROINFUSION 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 42-day FDA review.

K832166 · Travenol Laboratories, S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
42d
Days
Class 2
Risk

K832166 is an FDA 510(k) clearance for the FLO-GARD 8500 MICROINFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Walker, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 42 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 K832166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1983
Decision Date August 16, 1983
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 K832166.
PUMPETTE AS8P-INFUSION PUMP
K831534 · Travenol Laboratories, S.A. · Sep 1983
LIFECARE MICRO PUMP
K832289 · Abbott Laboratories · Sep 1983
GRASEBY DYNAMICS MS302 SYRINGE DRIVER
K832410 · Intermedics, Inc. · Sep 1983
SIMPLICITY PLUS
K831761 · Critikon Company, LLC · Aug 1983
INFUTROL 7000 INFUSION PUMP
K832008 · Valleylab, Inc. · Aug 1983
PROMINJET PUMP
K832120 · Abbott Laboratories · Aug 1983