Cleared Traditional

I.V. TRANSFER SPIKE (K842678) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 237
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K842678.
MICRO VOLUME DOUBLE LINE EXTENSION SET
K850061 · Travenol Laboratories, S.A. · Mar 1985
ANTI-ASPIRATION VALVE
K843748 · Travenol Laboratories, S.A. · Jan 1985
MINISET VEIN INFUSION SETS
K843631 · Travenol Laboratories, S.A. · Oct 1984
HARVARD ANTI-REFLUX Y-SET
K840760 · C.R. Bard, Inc. · Apr 1984
QUIK LOK
K840878 · Abbott Laboratories · Mar 1984
CONTINU-FLO SOLUTION ADMIN. 2C9102
K834289 · Travenol Laboratories, S.A. · Jan 1984