Cleared Traditional

K860605 - FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER

K860605 is an FDA 510(k) clearance for FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC..., manufactured by Migada, Ltd.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K860605 · Migada, Ltd. · General Hospital
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Mar 1986
Decision
33d
Days
Class 2
Risk

K860605 is an FDA 510(k) clearance for the FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER. 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 March 24, 1986 after a review of 33 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

FDA 510(k) Submission Details - K860605

510(k) Number K860605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date March 24, 1986
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 808
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K860605.
NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET
K860157 · Quest Medical, Inc. · Apr 1986
CLINISET INFUSION SET
K860322 · Zimmar Consulting , Ltd. · Apr 1986
SOLUTION ADMINISTRATION SET
K860541 · Travenol Laboratories, S.A. · Mar 1986
SOLUTION ADMINISTRATION SETS
K860272 · Travenol Laboratories, S.A. · Mar 1986
CHURCHILL - HBC VENTED BALL CHECK IV SET
K854658 · Churchill Corp. · Jan 1986
IVAC CONTROLLED RELEASE INFUSION SYSTEM
K854574 · Y · Jan 1986