Cleared Traditional

K860272 - SOLUTION ADMINISTRATION SETS

K860272 is an FDA 510(k) clearance for SOLUTION ADMINISTRATION 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 50-day FDA review.

K860272 · Travenol Laboratories, S.A. · General Hospital
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Mar 1986
Decision
50d
Days
Class 2
Risk

K860272 is an FDA 510(k) clearance for the SOLUTION ADMINISTRATION 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 March 18, 1986 after a review of 50 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 - K860272

510(k) Number K860272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1986
Decision Date March 18, 1986
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 K860272.
SOLUTION ADMINISTRATION SET
K860541 · Travenol Laboratories, S.A. · Mar 1986
IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS
K854365 · Migada, Ltd. · Mar 1986
FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER
K860605 · Migada, Ltd. · Mar 1986
RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER
K854806 · Grant Medical Center · Feb 1986
IN LINE VALVE CATALOG NO. 2000A
K854965 · Rao Medical Devices, Inc. · Feb 1986
JMS INFUSION SET
K860242 · Sturbridge Medical · Feb 1986
K860272 · SOLUTION ADMINISTRATION SETS
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