Cleared Traditional

K843631 - MINISET VEIN INFUSION SETS

K843631 is an FDA 510(k) clearance for MINISET VEIN INFUSION SETS, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K843631 · Travenol Laboratories, S.A. · General Hospital
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Oct 1984
Decision
32d
Days
Class 2
Risk

K843631 is an FDA 510(k) clearance for the MINISET VEIN INFUSION SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on October 19, 1984 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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.

FDA 510(k) Submission Details - K843631

510(k) Number K843631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date October 19, 1984
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 1173
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K843631.
GENT-L-KARE STERILE I.V. START KIT
K844255 · Geneva Laboratories, Inc. · Dec 1984
UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM
K843090 · Geneva Laboratories, Inc. · Dec 1984
FLU VEN I.V. SET 0153-C PERMA-SET
K843692 · Venusa , Ltd. · Oct 1984
EXTENSION SET W/INJECTION SITE
K842984 · Med Fusion Systems, Inc. · Oct 1984
STERILE DESIGN-CUSTOM STERILE IV KIT
K842351 · Sterile Design, Inc. · Oct 1984
PROVIDER BAG SPIKE W/12 MICROBORE EXTEN
K843463 · Pancretec, Inc. · Oct 1984
K843631 · MINISET VEIN INFUSION SETS
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