Cleared Traditional

K863304 - PRESELECTED FLOW RATE I.V. SET

K863304 is an FDA 510(k) clearance for PRESELECTED FLOW RATE I.V. SET, 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 106-day FDA review.

K863304 · Migada, Ltd. · General Hospital
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Dec 1986
Decision
106d
Days
Class 2
Risk

K863304 is an FDA 510(k) clearance for the PRESELECTED FLOW RATE I.V. 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 December 9, 1986 after a review of 106 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

FDA 510(k) Submission Details - K863304

510(k) Number K863304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date December 09, 1986
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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 K863304.
NORFOLK MEDICAL BUTTERFLY INFUSION SET
K870188 · Norfolk Medical Products, Inc. · Feb 1987
MANAN CONTRAST MEDIA ADMINISTRATION SET
K864405 · Manan Manufacturing Co., Inc. · Dec 1986
CRIS ADAPTED WITH VOLUME LIMITING BAG
K864164 · Y · Dec 1986
SECONDARY SET LOCK
K864338 · Travenol Laboratories, S.A. · Nov 1986
BAG SPIKE EXTENSION SET
K863814 · Med Fusion Systems, Inc. · Oct 1986
EXEL BUTTERFLY SCALP VEIN SET
K862491 · Exel Intl. · Aug 1986