Cleared Traditional

K833958 - FLO-GARD 8100 INFUSION PUMP

K833958 is an FDA 510(k) clearance for FLO-GARD 8100 INFUSION PUMP, 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 43-day FDA review.

K833958 · Travenol Laboratories, S.A. · General Hospital
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Dec 1983
Decision
43d
Days
Class 2
Risk

K833958 is an FDA 510(k) clearance for the FLO-GARD 8100 INFUSION 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 December 29, 1983 after a review of 43 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 - K833958

510(k) Number K833958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1983
Decision Date December 29, 1983
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 K833958.
INFUSION PUMP
K832470 · Delta Medical Industries · Feb 1984
LIFECARE 4/HOMECARE - 4H PUMP
K840263 · Abbott Laboratories · Feb 1984
GILLETTE SABRE SYRINGE
K833655 · Intermedics, Inc. · Dec 1983
VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY
K832285 · Travenol Laboratories, S.A. · Dec 1983
BETATRON I AMBULATORY INSULIN PUMP
K833306 · Cardiac Pacemakers, Inc. · Nov 1983
ACCU-RYNGE PUMP SP-250
K830389 · Delta Medical Industries · Sep 1983