Cleared Traditional

BAG SPIKE EXTENSION SET (K863814) - FDA 510(k) Clearance

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

K863814 · Med Fusion Systems, Inc. · General Hospital
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Oct 1986
Decision
14d
Days
Class 2
Risk

K863814 is an FDA 510(k) clearance for the BAG SPIKE EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Med Fusion Systems, Inc. (Norcross, US). The FDA issued a Cleared decision on October 14, 1986 after a review of 14 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 K863814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1986
Decision Date October 14, 1986
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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

All 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K863814.
CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE
K873894 · Travenol Laboratories, S.A. · Nov 1987
SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.
K870940 · Travenol Laboratories, S.A. · Mar 1987
SECONDARY SET LOCK
K864338 · Travenol Laboratories, S.A. · Nov 1986
SOLUTION ADMINISTRATION SET
K860541 · Travenol Laboratories, S.A. · Mar 1986
SOLUTION ADMINISTRATION SETS
K860272 · Travenol Laboratories, S.A. · Mar 1986
MICRO VOLUME DOUBLE LINE EXTENSION SET
K850061 · Travenol Laboratories, S.A. · Mar 1985