Cleared Traditional

IV FILTER EXTENSION SET (K860803) - FDA 510(k) Clearance

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

K860803 · Med Fusion Systems, Inc. · General Hospital
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Apr 1986
Decision
36d
Days
Class 2
Risk

K860803 is an FDA 510(k) clearance for the IV FILTER EXTENSION SET. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Med Fusion Systems, Inc. (Norcross, US). The FDA issued a Cleared decision on April 9, 1986 after a review of 36 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 Med Fusion Systems, Inc. devices

Submission Details

510(k) Number K860803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date April 09, 1986
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPB Filter, Infusion Line
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 - FPB Filter, Infusion Line

All 23
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K860803.
IVEX-HP96 EXTENDED LIFE FILTER SET
K920736 · Abbott Laboratories · Apr 1993
IVEX-TPN EXTENSION FILTER SET
K913308 · Abbott Laboratories · Jan 1992
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K865029 · Travenol Laboratories, S.A. · Apr 1987
AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
K860746 · Travenol Laboratories, S.A. · Apr 1986
IVEX-INT
K833684 · Abbott Laboratories · Dec 1983
CONTINU-FLO SOLUTION ADMINISTRATION
K831668 · Travenol Laboratories, S.A. · Aug 1983