Cleared Traditional

K842678 - I.V. TRANSFER SPIKE

K842678 is an FDA 510(k) clearance for I.V. TRANSFER SPIKE, manufactured by Lyphomed, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K842678 · Lyphomed, Inc. · General Hospital
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Oct 1984
Decision
91d
Days
Class 2
Risk

K842678 is an FDA 510(k) clearance for the I.V. TRANSFER SPIKE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Lyphomed, Inc. (Melrose Park, US). The FDA issued a Cleared decision on October 9, 1984 after a review of 91 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 Lyphomed, Inc. devices

FDA 510(k) Submission Details - K842678

510(k) Number K842678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date October 09, 1984
Days to Decision 91 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 faster than avg
Panel avg: 129d · This submission: 91d
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 835
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K842678.
ANTI-ASPIRATION VALVE
K843748 · Travenol Laboratories, S.A. · Jan 1985
MINISET VEIN INFUSION SETS
K843631 · Travenol Laboratories, S.A. · Oct 1984
EXTENSION SET W/INJECTION SITE
K842984 · Med Fusion Systems, Inc. · Oct 1984
IVAC C80014 Y SOLUTION ADMIN. SET
K843185 · Y · Sep 1984
FLUID ADMINISTRATION LINE W/SPIKE 14-923
K842858 · Norton Performance Plastics Corp. · Sep 1984
T-TYPE IV EXTENSION SET
K843249 · Strato Medical Corp. · Sep 1984