Cleared Traditional

K854365 - IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854365 · Migada, Ltd. · General Hospital
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Mar 1986
Decision
146d
Days
Class 2
Risk

K854365 is an FDA 510(k) clearance for the IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Migada, Ltd. (P.O. B. 211 Rehovot 76101, IL). The FDA issued a Cleared decision on March 24, 1986 after a review of 146 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Migada, Ltd. devices

Submission Details

510(k) Number K854365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date March 24, 1986
Days to Decision 146 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
18d slower than avg
Panel avg: 128d · This submission: 146d
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

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