Cleared Traditional

K860952 - I.V. SET WITH AND WITHOUT AIR VENT

K860952 is an FDA 510(k) clearance for I.V. SET WITH AND WITHOUT AIR VENT, 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 167-day FDA review.

K860952 · Migada, Ltd. · General Hospital
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Aug 1986
Decision
167d
Days
Class 2
Risk

K860952 is an FDA 510(k) clearance for the I.V. SET WITH AND WITHOUT AIR VENT. 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 August 27, 1986 after a review of 167 days - an extended review 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: 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

FDA 510(k) Submission Details - K860952

510(k) Number K860952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1986
Decision Date August 27, 1986
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
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 K860952.
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K864164 · Y · Dec 1986
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K864338 · Travenol Laboratories, S.A. · Nov 1986
BAG SPIKE EXTENSION SET
K863814 · Med Fusion Systems, Inc. · Oct 1986
EXEL BUTTERFLY SCALP VEIN SET
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LUER LOCK ADAPTER/NUT
K862653 · Mallinckrodt Critical Care · Jul 1986
TIMELINE VENIPUNCTURE SYSTEM
K860609 · Ipax, Inc. · Jun 1986