Cleared Traditional

K860201 - PARENTERAL ADMINISTRATION SET

K860201 is the FDA 510(k) clearance for PARENTERAL ADMINISTRATION SET by Migada, Ltd.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K860201 · Migada, Ltd. · General Hospital
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Feb 1986
Decision
13d
Days
Class 2
Risk

K860201 is an FDA 510(k) clearance for the PARENTERAL ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Migada, Ltd. (Israel, IL). The FDA issued a Cleared decision on February 4, 1986 after a review of 13 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.

View all Migada, Ltd. devices

Submission Details

510(k) Number K860201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date February 04, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 129d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 279
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K860201.
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K860541 · Travenol Laboratories, S.A. · Mar 1986
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TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET
K854446 · Terumo Medical Corp. · Jan 1986
CONTROLLED RELEASE INFUSION SYSTEM(CRIS)
K852488 · Y · Jun 1985