Cleared Traditional

K943095 - IV TRANSFER SPIKE

K943095 is the FDA 510(k) clearance for IV TRANSFER SPIKE by Migada, Ltd.. It is a Class 2 General Hospital device (product code LHI) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K943095 · Migada, Ltd. · General Hospital
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Sep 1994
Decision
94d
Days
Class 2
Risk

K943095 is an FDA 510(k) clearance for the IV TRANSFER SPIKE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Migada, Ltd. (Kiryat Shmona, IL). The FDA issued a Cleared decision on September 30, 1994 after a review of 94 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

Submission Details

510(k) Number K943095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1994
Decision Date September 30, 1994
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 65
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K943095.
COMBIPROT EMERGENCY ENFUSION DEVICE
K970359 · B.Braun Medical, Inc. · Mar 1997
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
K960466 · Abbott Laboratories · May 1996
FORMULATION PREPARATION DEVICE
K955398 · B.Braun Medical, Inc. · Apr 1996
DIPRIVAN LUER CONNECTOR
K935274 · Ohmeda Medical · Mar 1994
INTERLINK UNIVERSAL VIAL ADAPTER
K924064 · Baxter Healthcare Corp · Apr 1993
NUTRIMIX MICROCOMPOUNDER
K921365 · Abbott Laboratories · Jun 1992